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DS - Health Care Technology

Listing of active documents part of the DS - Health Care Technology.

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DS DS/EN ISO 10322- 1

Ophthalmic optics - Semi-finished spectacle lens blanks - Part 1: Specifications for single-vision and multifocal lens blanks

DS DS/EN ISO 10322- 2

Ophtalmic optics - Semi-finished spectacle lens blanks - Part 2: Specifications for progressive power lens blanks

DS DS/EN ISO 10323

Dental rotary instruments - Bore diameters for discs and wheels

DS DS/EN ISO 10338

Optics and optical instruments - Contact lenses - Determination of curvature

DS DS/EN ISO 10339

Ophthalmic optics - Contact lenses - Determination of water content of hydrogel lenses

DS DS/EN ISO 10340

Optics and optical instruments - Contact lenses - Method for the determining the extractable substances

DS DS/EN ISO 10341

Ophthalmic instruments - Refractor heads

DS DS/EN ISO 10342

Ophthalmic instruments - Eye refractometers

DS DS/EN ISO 10343

Ophthalmic instruments - Ophthalmometers

DS DS/EN ISO 10344

Optics and optical instruments - Contact lenses - Saline solution for contact lens testing

DS DS/EN ISO 10451

Dental implant systems - Contents of technical file

DS DS/EN ISO 10477

Dentistry - Polymer-based crown and bridge materials

DS DS/EN ISO 10535

Hoists for the transfer of disabled persons - Requirements and test methods

DS DS/EN ISO 10555- 1

Sterile, single use intravascular catheters - Part 1: General requirements

DS DS/EN ISO 10555- 1/A1

Sterile, single-use intravascular catheters - Part 1: General requirements-(AMENDS DS/EN ISO 10555-1)

DS DS/EN ISO 10555- 1/A2

Sterile, single use intravascular catheters - Part 1: General requirements-(AMENDS DS/EN ISO 10555-1)

DS DS/EN ISO 10555- 2

Sterile, single-use intravascular catheters - Part 2: Angiographic catheters

DS DS/EN ISO 10555- 2/AC

Sterile, single-use intravascular catheters - Part 2: Angiographic catheters

DS DS/EN ISO 10555- 3

Sterile, single-use intravascular catheters - Part 3: Central venous catheters

DS DS/EN ISO 10555- 3/AC

Sterile, single-use intravascular catheters - Part 3: Central venous catheters

DS DS/EN ISO 10555- 4

Sterile, single-use intravascular catheters - Part 4: Balloon dilatation catheters

DS DS/EN ISO 10555- 4/AC

Sterile, single-use intravascular catheters - Part 4: Balloon dilatation catheters

DS DS/EN ISO 10555- 5

Sterile, single-use intravascular catheters - Part 5: Over-needle peripheral catheters

DS DS/EN ISO 10555- 5/A1

Sterile, single-use intravascular catheters - Part 5: Over-needle peripheral catheters-, (AMENDS DS/EN ISO 10555-5)

DS DS/EN ISO 10555- 5/AC

Sterile, single-use intravascular catheters - Part 5: Over-needle peripheral catheters

DS DS/EN ISO 10637

Dental equipment - High- and medium-volume suction systems

DS DS/EN ISO 10650- 1

Dentistry Powered polymerization activators Part 1: Quartz tungsten halogen lamps-Replaces: DS/ISO/TS 10650

DS DS/EN ISO 10651- 2

Lung ventilators for medical use - Particular requirements for basic safety and essential performance - Part 2: Home care ventilators for ventilator-dependent patients

DS DS/EN ISO 10651- 4

Lung ventilators - Part 4: Particular requirements for operator-powered resuscitators

DS DS/EN ISO 10651- 6

Lung ventilators for medical use - Particular requirements for basic safety and essential performance - Part 6: Home-care ventilatory support devices

DS DS/EN ISO 10938

Ophthalmic instruments - Chart projectors

DS DS/EN ISO 10939

Ophthalmic instruments - Slit-lamp microscopes

DS DS/EN ISO 10939/AC

Ophthalmic instruments - Slit-lamp microscopes

DS DS/EN ISO 10940

Ophthalmic instruments - Fundus cameras

DS DS/EN ISO 10942

Ophthalmic instruments - Direct ophthalmoscopes

DS DS/EN ISO 10943

Ophthalmic instruments - Indirect ophtalmoscopes

DS DS/EN ISO 10944

Ophthalmic instruments - Synopthophores

DS DS/EN ISO 10993- 1

Biological evaluation of medical devices - Part 1: Evaluation and testing

DS DS/EN ISO 10993- 10

Biological evaluation of medical devices - Part 10: Tests for irritation and delayed-type hypersensitivity

DS DS/EN ISO 10993- 11

Biological evaluation of medical devices - Part 11: Tests for systemic toxicity

DS DS/EN ISO 10993- 12

Biological evaluation of medical devices - Part 12: Sample preparation and reference materials

DS DS/EN ISO 10993- 13

Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric medical devices

DS DS/EN ISO 10993- 14

Biological evaluation of medical devices - Part 14: Identification and quantification of degradation products from ceramics

DS DS/EN ISO 10993- 15

Biological evaluation of medical devices - Part 15: Identification and quantification of degradation products from metals and alloys

DS DS/EN ISO 10993- 16

Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables

DS DS/EN ISO 10993- 17

Biological evaluation of medical devices - Part 17: Establishment of allowable limits for leachable substances

DS DS/EN ISO 10993- 18

Biological evaluation of medical devices Part 18: Chemical characterization of materials

DS DS/EN ISO 10993- 2

Biological evaluation of medical devices - Part 2: Animal welfare requirements

DS DS/EN ISO 10993- 3

Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity

DS DS/EN ISO 10993- 4

Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood

DS DS/EN ISO 10993- 5

Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity

DS DS/EN ISO 10993- 7

Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization rediduals

DS DS/EN ISO 10993- 8

Biological evaluation of medical devices - Part 8: Selection and qualification of reference materials for biological tests

DS DS/EN ISO 10993- 9

Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products

DS DS/EN ISO 11070

Sterile single-use intravascular catheter introducers

DS DS/EN ISO 11140- 1

Sterilization of health care products Chemical indicators Part 1: General requirements

DS DS/EN ISO 11143

Dental equipment - Amalgam separators

DS DS/EN ISO 11143/AC

Dental equipment - Amalgam separators

DS DS/EN ISO 11144

Dental equipment - Connections for supply and waste lines

DS DS/EN ISO 11199- 1

Walking aids manipulated by both arms - Requirements and test methods - Part 1: Walking frames

DS DS/EN ISO 11199- 2

Walking aids manipulated by both arms - Requirements and test methods - Part 2: Rollators

DS DS/EN ISO 11199- 3

Walking aids manipulated by both arms Requirements and test methods Part 3: Walking tables

DS DS/EN ISO 11244

Dental brazing investments

DS DS/EN ISO 11245

Dental restorations - Phosphate-bonded refractory die materials

DS DS/EN ISO 11246

Dental ethyl silicate bonded casting investments

DS DS/EN ISO 11334- 1

Walking aids manipulated by one arm - Requirements and test methods - Part 1: Elbow crutches

DS DS/EN ISO 11334- 4

Walking aids manipulated by one arm - Requirements and test methods - Part 4: Walking sticks with three or more legs

DS DS/EN ISO 1135- 4

Transfusion equipment for medical use - Part 4: Transfusion sets for single use

DS DS/EN ISO 11381

Optics and optical instruments - Ophthalmic optics - Screw threads

DS DS/EN ISO 11498

Dental handpieces - Dental low-voltage electrical motors

DS DS/EN ISO 11499

Dental cartridges for local anaesthetics

DS DS/EN ISO 11539

Ophthalmic optics - Contact lenses - Classification of contact lenses and contact lens materials

DS DS/EN ISO 11608- 1

Pen-injectors for medical use - Part 1: Pen-injectors - Requirements and test methods

DS DS/EN ISO 11608- 2

Pen-injectors for medical use - Part 2: Needles - Requirements and test methods

DS DS/EN ISO 11608- 3

Pen-injectors for medical use - Part 3: Finished cartridges - Requirements and test methods

DS DS/EN ISO 11609

Dentistry - Toothpastes - Requirements, test methods and marking

DS DS/EN ISO 11683

Packaging - Tactile warnings of danger - Requirements

DS DS/EN ISO 11715- 1

Ophthalmic optics - Format of digital data files for data transfer for profiling of spectacle lenses - Part 1: Two-dimensional tracers

DS DS/EN ISO 11737- 2

Sterilization of medical devices - Microbiological methods - Part 2: Tests of sterility performed in the validation of a sterilization process

DS DS/EN ISO 11810- 1

Lasers and laser-related equipment Test method and classification for the laser resistance of surgical drapes and/or patient protective covers Part 1: Primary ignition and penetration

DS DS/EN ISO 11978

Ophtmalmic optics - Contact lenses - Contact lenses and contact lens care products - Information to be supplied by the manufacturer

DS DS/EN ISO 11979- 1

Opthalmic implants - Intraocular lenses - Part 1: Vocabulary

DS DS/EN ISO 11979- 2

Ophthalmic implants - Intraocular lenses - Part 2: Optical properties and tests methods

DS DS/EN ISO 11979- 4

Ophthalmic implants - Intraocular lenses - Part 4: Labelling and information

DS DS/EN ISO 11980

Ophthalmic optics - Contact lenses and contact lens care products - Guidance for clinical investigations

DS DS/EN ISO 11981

Ophthalmic optics - Contact lenses and contact lens care products - Determination of physical compability of contact lens care products with contact lenses

DS DS/EN ISO 11984

Ophthalmic optics - Contact lenses - Determination of rigid lens flexure and breakage

DS DS/EN ISO 11985

Ophthalmic optics - Contact lenses - Ageing by exposure to UV and visible radiation (in-vitro method)

DS DS/EN ISO 11986

Ophthalmic optics - Contact lenses and contact lens care products - Guidelines for the determination of preservative uptake and release

DS DS/EN ISO 11987

Optics and optical instruments - Contact lenses - Determination of shelf-life

DS DS/EN ISO 11990

Optics and optical instruments - Lasers and laser-related equipment - Determination of laser resistance of tracheal tube shafts

DS DS/EN ISO 12163

Dental baseplate/modelling wax

DS DS/EN ISO 12864

Ophthalmic optics - Contact lenses - Determination of scattered light

DS DS/EN ISO 12865

Ophthalmic instruments - Retinoscopes

DS DS/EN ISO 12866

Ophthalmic instruments - Perimeters

DS DS/EN ISO 12867

Ophthalmic instruments - Trial frames

DS DS/EN ISO 12870

Ophthalmic optics - Spectacle frames - Requirements and test methods

DS DS/EN ISO 13212

Ophthalmic optics - Contact lens care products - Guidelines for the determination of shelf-life

DS DS/EN ISO 13230

Ophtalmic optics - Bar code specifications

DS DS/EN ISO 13294

Dental handpieces - Dental air-motors

DS DS/EN ISO 13295

Dental rotary instruments - Mandrels

DS DS/EN ISO 13397- 1

Periodontal curettes, dental scalers and excavators - Part 1: General requirements

DS DS/EN ISO 13397- 2

Dentistry - Periodontal curettes, dental scalers and excavators - Part 2: Periodontal curettes - GR-type

DS DS/EN ISO 13402

Surgical and dental hand instruments - Determination of resistance against autoclaving, corrosion and thermal exposure

DS DS/EN ISO 13485

Medical devices - Quality management systems - Requirements for regulatory purposes

DS DS/EN ISO 13485

Quality systems - Medical devices - Particular requirements for the application of EN ISO 9001

DS DS/EN ISO 13488

Quality systems - Medical devices - Particular requirements for the application of EN ISO 9002

DS DS/EN ISO 13666

Ophtalmics optics - Spectacles lenses - Vocabulary

DS DS/EN ISO 13716

Dentistry - Reversible-irreversible hydrocolloid impression material systems

DS DS/EN ISO 13897

Dentistry - Amalgam capsules

DS DS/EN ISO 14155- 1

Clinical investigation of medical devices for human subjects - Part 1: General requirements

DS DS/EN ISO 14155- 2

Clinical investigation of medical devices for human subjects - Part 2: Clinical investigation plans

DS DS/EN ISO 14160

Sterilization of single-use medical devices incorporating materials of animal origin - Validation and routine control of sterilization by liquid chemical sterilants

DS DS/EN ISO 14161

Sterilization of health care products - Biological indicators - Guidance for the selection, use and interpretation of results

DS DS/EN ISO 14233

Dentistry - Polymer-based die materials

DS DS/EN ISO 14356

Dentistry - Duplicating material

DS DS/EN ISO 14408

Tracheal tubes designed for laser surgery Requirements for marking and accompanying information

DS DS/EN ISO 14534

Ophthalmic optics - Contact lenses and contact lens care products - Fundamental requirements

DS DS/EN ISO 14602

Non-active surgical implants - Implants for Osteosynthesis - Particular requirements

DS DS/EN ISO 14630

Non-active surgical implants - General requirements

DS DS/EN ISO 14727

Dental implants - Prefabricated parts connecting suprastructures to dental implants - Contents of technical file

DS DS/EN ISO 14727/AC

Dental implants - Prefabricated parts connecting suprastructures to dental implants - Contents of technical file

DS DS/EN ISO 14729

Ophthalmic optics - Contact lens care products - Microbiological requirements and test methods for products and regimens for hygienic management of contact lenses

DS DS/EN ISO 14730

Ophthalmic optics - Contact lens care products - Antimicrobial preservative efficacy testing and guidance on determining discard date

DS DS/EN ISO 14730/AC

Ophthalmic optics - Contact lens care products - Antimicrobial preservative efficacy testing and guidance on determining discard date

DS DS/EN ISO 14801

Dentistry - Fatigue test for endosseous dental implants

DS DS/EN ISO 14889

Ophthalmic optics - Spectacle lenses - Fundamental requirements for uncut finished lenses

DS DS/EN ISO 14937/AC

Sterilization of health care products - General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices-AC: 03/31/2005

DS DS/EN ISO 14971

Medical devices Application of risk management to medical devices-Amendment 1: 4/30/2003; AC: 4/19/2005

DS DS/EN ISO 15001

Anaesthetic and respiratory equipment - Compatibility with oxygen

DS DS/EN ISO 15004

Ophthalmic instruments - Fundamental requirements and test methods

DS DS/EN ISO 15087- 1

Dental elevators - Part 1: General requirements

DS DS/EN ISO 15087- 2

Dental elevators - Part 2: Warwick James elevators

DS DS/EN ISO 15087- 3

Dental elevators - Part 3: Cryer elevators

DS DS/EN ISO 15087- 4

Dental elevators - Part 4: Coupland elevators

DS DS/EN ISO 15087- 5

Dental elevators - Part 5: Bein elevators

DS DS/EN ISO 15087- 6

Dental elevators - Part 6: Flohr elevators

DS DS/EN ISO 15098- 1

Dental tweezers - Part 1: General requirements

DS DS/EN ISO 15098- 2

Dental tweezers - Part 2: Meriam types

DS DS/EN ISO 15098- 3

Dental tweezers - Part 3: College types

DS DS/EN ISO 15189

Medical laboratories - Particular requirements for quality and competence

DS DS/EN ISO 15195

Laboratory medicine - Requirements for reference measurement laboratories

DS DS/EN ISO 15197

In vitro diagnostic test systems - Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus-AC: 05/23/2005

DS DS/EN ISO 15225

Nomenclature - Specification for a nomenclature system for medical devices for the purpose of regulatory data exchange-Amendment 1:2/24/2004; Amendment 2:7/18/2005

DS DS/EN ISO 15253

Ophthalmic optics and instruments - Optical devices for enchancing low vision

DS DS/EN ISO 15253/AC

Ophthalmic optics and instruments - Optical devices for enchancing low vision

DS DS/EN ISO 15254

Ophthalmic optics and instruments - Electro-optical devices for enhancing low vision

DS DS/EN ISO 15606

Dental handpieces - Air-powered scalers and scaler tips

DS DS/EN ISO 1562

Dentistry - Casting gold alloys

DS DS/EN ISO 1564

Dental aqueous impresson materials based on agar

DS DS/EN ISO 1567

Dentistry - Denture base polymers

DS DS/EN ISO 15747

Plastics containers for intravenous injection

DS DS/EN ISO 15798

Ophthalmic implants - Ophthalmic viscosurgical devices

DS DS/EN ISO 15854

Dentistry Casting and baseplate waxes

DS DS/EN ISO 15882

Sterilization of health care products - Chemical indicators - Guidance for selection, use and interpretation of results

DS DS/EN ISO 16021

Urine-absorbing aids - Basic principles for evaluation of single-use adult-incontinence-absorbing aids from the perspective of users and caregivers

DS DS/EN ISO 16054

Implants for surgery - Minimum data sets for surgical implants

DS DS/EN ISO 16284

Ophthalmic optics - Information interchange for ophthalmic optical equipment

DS DS/EN ISO 16408

Dentistry - Oral hygiene products - Oral rinses

DS DS/EN ISO 16671

Ophthalmic implants - Irrigating solutions for ophthalmic surgery

DS DS/EN ISO 16672

Ophthalmic implants - Ocular endotamponades

DS DS/EN ISO 16744

Dentistry - Base metal materials for fixed dental restorations

DS DS/EN ISO 17510- 1

Sleep apnoea breathing therapy - Part 1: Sleep apnoea breathing therapy devices

DS DS/EN ISO 17510- 2

Sleep apnoea breathing therapy - Part 2: Masks and application accessories

DS DS/EN ISO 17511

In vitro diagnostic medical devices - Measurement of quantities in biological samples - Metrological traceability of values assigned to calibrators and control materials

DS DS/EN ISO 17664

Sterilization of medical devices - Information to be provided by the manufacturer for the processing of resterilizable medical devices

DS DS/EN ISO 1797- 1

Dental rotary instruments - Shanks - Part 1: Shanks made of metals

DS DS/EN ISO 1797- 1/A1

Dental rotary instruments - Shanks - Part 1: Shanks made of metals- (AMENDS DS/EN ISO 1797-1)

DS DS/EN ISO 1797- 2

Dental rotary instruments - Shanks - Part 2: Shanks made of plastics

DS DS/EN ISO 18153

In vitro diagnostic medical devices - Measurement of quantities in biological samples - Metrological traceability of values for catalytic concentration of enzymes assigned to calibrators and control materials

DS DS/EN ISO 18777

Transportable liquid oxygen systems for medical use Particular requirements

DS DS/EN ISO 18778

Respiratory equipment Infant monitors Particular requirements

DS DS/EN ISO 18779

Medical devices for conserving oxygen and oxygen mixtures Particular requirements

DS DS/EN ISO 1942- 5

Dental vocabulary - Part 5: Terms associated with testing

DS DS/EN ISO 19980

Ophthalmic instruments Corneal topographers

DS DS/EN ISO 21530

Dentistry - Materials used for dental equipment surfaces - Determinaton of resistance to chemical disinfectants

DS DS/EN ISO 21533

Dentistry - Reusable cartridge syringes intended for intraligamentary injections

DS DS/EN ISO 2157

Dental rotary instruments - Nominal diameters and designation code number

DS DS/EN ISO 22374

Dentistry Dental handpieces Electrical-powered scalers and scaler tips

DS DS/EN ISO 22612

Clothing for protection against infectious agents Test method for resistance to dry microbial penetration

DS DS/EN ISO 22803

Dentistry Membrane materials for guided tissue regeneration in oral and maxillofacial surgery Contents of a technical file

DS DS/EN ISO 24234

Dentistry - Mercury and alloys for dental amalgam

DS DS/EN ISO 3107

Dentistry - Zinc oxide/eugenol and zinc oxide/non-eugenol cements

DS DS/EN ISO 3336

Dentistry. Synthetic polymer teeth

DS DS/EN ISO 3630- 1

Dental root-canal instruments - Part 1: Files, reamers, barbed broaches, rasps, paste carriers, explorers and cotton broaches

DS DS/EN ISO 3630- 2

Dental root-canal instruments - Part 2: Enlargers

DS DS/EN ISO 3630- 3

Dental root-canal instruments - Part 3: Condensers, pluggers and spreaders

DS DS/EN ISO 3823- 1

Dental rotary instruments - Burs - Part 1: Steel and carbide burs

DS DS/EN ISO 3823- 2

Dentistry - Rotary bur instruments - Part 2: Finishing burs

DS DS/EN ISO 3826- 1

Plastics collapsible containers for human blood and blood components - Part 1: Conventional containers

DS DS/EN ISO 3950

Dentistry - Designation system for teeth and areas of the oral cavity

DS DS/EN ISO 4049

Dentistry - Polymer-based filling, restorative and luting materials

DS DS/EN ISO 407

Small medical gas cylinders Pin-index yoke-type valve connections

DS DS/EN ISO 4073

Dental equipment Items of dental equipment at the working place Identification system

DS DS/EN ISO 4074

Natural latex rubber condoms - Requirements and tests methods

DS DS/EN ISO 4074/AC

Natural latex rubber condoms - Requirements and tests methods

DS DS/EN ISO 4135

Anaesthetic and respiratory equipment - Vocabulary

DS DS/EN ISO 4823

Dentistry - Elastomeric impression materials

DS DS/EN ISO 4824

Dentistry - Ceramic denture teeth

DS DS/EN ISO 4824/A1

Dentistry - Ceramic denture teeth-(AMENDS DS/EN ISO 4824)

DS DS/EN ISO 5356- 1

Anaesthetic and respiratory equipment - Conical connectors - Part 1: Cones and sockets

DS DS/EN ISO 5366- 1

Anaesthetic and respiratory equipment - Tracheostomy tubes - Part 1: Tubes and connectors for use in adults

DS DS/EN ISO 595- 2

Reusable all-glass or metal-and-glass syringes for medical use - Part 2: Design, performance requirements and tests

DS DS/EN ISO 6009

Hypodermic needles for single use - Colour coding for identification

DS DS/EN ISO 6360- 1

Dentistry - Number coding system for rotary instruments - Part 1: General characteristics

DS DS/EN ISO 6360- 2

Dentistry - Number coding system for rotary instruments - Part 2: Shapes

DS DS/EN ISO 6360- 3

Dentistry Number coding system for rotary instruments Part 3: Specific characteristics of burs and cutters

DS DS/EN ISO 6360- 4

Dentistry - Number coding system for rotary instruments - Part 4: Specific characteristics of diamond instruments

DS DS/EN ISO 6360- 6

Dentistry - Number coding system for rotary instruments - Part 6: Specific characteristics of abrasive instruments

DS DS/EN ISO 6871- 1

Dental base metal casting alloys - Part 1: Cobalt-based alloys

DS DS/EN ISO 6871- 2

Dental base metal casting alloys - Part 2: Nickel-based alloys

DS DS/EN ISO 6872

Dental ceramic

DS DS/EN ISO 6873

Dental gypsum products

DS DS/EN ISO 6874

Dentistry Polymer-based pit and fissure sealants

DS DS/EN ISO 6875

Dental equipment - Dental patient chair

DS DS/EN ISO 6876

Dental root canal sealing materials

DS DS/EN ISO 6877

Dental root-canal obturating points

DS DS/EN ISO 7153- 1

Surgical instruments - Metallic Materials - Part 1: Stainless steel

DS DS/EN ISO 7376

Anaesthetic and respiratory equipment - Laryngoscopes for tracheal intubation

DS DS/EN ISO 7405

Dentistry - Preclinical evaluation of biocompatibility of medical devices used in dentistry - Test methods for dental materials

DS DS/EN ISO 7439

Copper-bearing intra-uterine contraceptive devices - Requirements, tests

DS DS/EN ISO 7490

Dental gypsum-bonded casting investments

DS DS/EN ISO 7491

Dental materials - Determination of colour stability

DS DS/EN ISO 7492

Dental explorerers

DS DS/EN ISO 7493

Dental Operator´s stool

DS DS/EN ISO 7494- 1

Dentistry Dental units Part 1: General requirements and test methods

DS DS/EN ISO 7494- 2

Dentistry - Dental units - Part 2: Water and air supply

DS DS/EN ISO 7551

Dental absorbent points

DS DS/EN ISO 7711- 1

Dental rotary instruments - Diamond instruments - Part 1: Dimensions, requirements, marking and packaging

DS DS/EN ISO 7711- 2

Dental rotary instruments - Diamond instruments - Part 2: Discs

DS DS/EN ISO 7711- 3

Dentistry - Diamond rotary instruments - Part 3: Grit sizes, designation and colour code

DS DS/EN ISO 7785- 1

Dental handpieces - Part 1: High-speed air turbine handpieces

DS DS/EN ISO 7785- 2

Dental handpieces - Part 2: Straight and geared angle handpieces

DS DS/EN ISO 7786

Dental rotary instruments - Laboratory abrasive instruments

DS DS/EN ISO 7787- 2

Dental rotary instruments - Cutters - Part 2: Carbide laboratory cutters

DS DS/EN ISO 7787- 4

Dental rotary instruments - Cutters - Part 4: Miniature carbide laboratory cutters

DS DS/EN ISO 7864

Sterile hypodermic needles for single use

DS DS/EN ISO 7885

Sterile dental injection needles for single use

DS DS/EN ISO 7886- 1

Sterile hypodermic syringes for single use - Part 1: Syringes for manual use

DS DS/EN ISO 7886- 2

Sterile hypodermic syringes for single use - Part 2: Syringes for use with power-driven syringe pumps

DS DS/EN ISO 7886- 3

Sterile hypodermic syringes for single use Part 3: Auto-disable syringes for fixed-dose immunization

DS DS/EN ISO 7998

Ophthalmic optics Spectacle frames Lists of equivalent terms and vocabulary

DS DS/EN ISO 8185/AC

Humidifiers for medical use - General requirements for humidification systems

DS DS/EN ISO 8282

Dental equipment - Mercury and alloy mixers and dispensers

DS DS/EN ISO 8320- 1

Contact lenses and contact lens care products - Vocabulary - Part 1: Contact lenses

DS DS/EN ISO 8320- 2

Contact lenses and contact lens care products - Vocabulary - Part 2: Contact lens care products

DS DS/EN ISO 8321- 1

Ophthalmic optics - Specifications for material, optical and dimensional properties of contact lenses - Part 1: Rigid corneal and scleral contact lenses

DS DS/EN ISO 8321- 2

Ophthalmic optics - Specifications for material, optical and dimensional properties of contact lenses - Part 2: Single-vision hydrogel lenses

DS DS/EN ISO 8325

Dentistry - Test methods for rotary instruments

DS DS/EN ISO 8359

Oxygen concentrators for medical use - Safety requirements

DS DS/EN ISO 8362- 1

Injection containers and accessories - Part 1: Injection vials made of glass tubing

DS DS/EN ISO 8362- 3

Injection containers and accessories - Part 3: Aluminium caps for injection vials

DS DS/EN ISO 8362- 4

Injection containers and accessories - Part 4: Injection vials made of moulded glass

DS DS/EN ISO 8429

Optics and optical instruments - Ophthalmology - Graduated dial scale

DS DS/EN ISO 8536- 1

Infusion equipment for medical use - Part 1: Infusion glass bottles-AC: 4/19/2005

DS DS/EN ISO 8536- 2

Infusion equipment for medical use - Part 2: Closures for infusion bottles

DS DS/EN ISO 8536- 3

Infusion equipment for medical use - Part 3: Aluminium caps for infusion bottles

DS DS/EN ISO 8536- 3/AC

Infusion equipment for medical use - Part 3: Aluminium caps for infusion bottles

DS DS/EN ISO 8536- 4

Infusion equipment for medical use - Part 4: Infusion sets for single use, gravity feed

DS DS/EN ISO 8536- 8

Infusion equipment for medical use - Part 8: Infusion equipment for use with pressure infusion apparatus

DS DS/EN ISO 8537

Sterile single-use syringes, with or without needle, for insulin

DS DS/EN ISO 8537/A1

Sterile single-use syringes, with or without needle, for insulin- (AMENDS DS/EN ISO 8537)

DS DS/EN ISO 8596

Ophthalmic optics - Visual acuity testing - Standard optotype and its presentation

DS DS/EN ISO 8597/COR.1

Optics and optical instruments - Visual acuity testing - Method of correlating optotypes

DS DS/EN ISO 8598

Optics and optical instruments - Focimeters

DS DS/EN ISO 8599

Optics and optical instruments - Contact lenses - Determination of the spectral and luminous transmittance

DS DS/EN ISO 8612

Ophthalmic instruments - Tonometers

DS DS/EN ISO 8624

Ophthalmic optics - Spectacle frames - Measuring system and terminology

DS DS/EN ISO 8669- 2

Urine collection bags - Part 2: Requirements and test methods

DS DS/EN ISO 8670- 2

Ostomy collection bags - Part 2: Requirements and test methods

DS DS/EN ISO 8835- 4

Inhalational anaesthesia systems - Part 4: Anaesthetic vapour delivery devices

DS DS/EN ISO 8835- 5

Inhalational anaesthesia systems - Part 5: Anaesthesia ventilators

DS DS/EN ISO 8871- 1

Elastomeric parts for parenterals and for devices for pharmaceutical use Part 1: Extractables in aqueous autoclavates

DS DS/EN ISO 8871- 3

Elastomeric parts for parenterals and for devices for pharmaceuticals use Part 3: Determination of releasedparticle count

DS DS/EN ISO 8872

Aluminium caps for transfusion, infusion and injection bottles - General requirements and test methods

DS DS/EN ISO 8891

Dental casting alloys with noble metal content of at least 25 % but less than 75 %

DS DS/EN ISO 8980- 1

Ophthalmic optics - Uncut finished spectacle lenses - Part 1: Specifications for single-vision and multifocal lenses

DS DS/EN ISO 8980- 2

Ophthalmic optics - Uncut finished spectacle lenses - Part 2: Specifications for progressive power lenses

DS DS/EN ISO 8980- 3

Ophthalmic optics Uncut finished spectacle lenses Part 3: Transmittance specifications and test methods

DS DS/EN ISO 8980- 4

Ophthalmic optics - Uncut finished spectacle lenses - Part 4: Specifications and test methods for anti-reflection coatings

DS DS/EN ISO 8980- 5

Ophthalmic optics Uncut finished spectacle lenses Part 5: Minimum requirements for spectacle lens surfaces claimed to be abrasion-resistant

DS DS/EN ISO 9173- 1

Dental extraction forceps - Part 1: Screw and pin joint types

DS DS/EN ISO 9187- 1

Injection equipment for medical use - Part 1: Ampoules for injectables-AC: 4/19/2005

DS DS/EN ISO 9187- 2

Injection equipment for medical use - Part 2: One-point-cut (OPC) ampoules

DS DS/EN ISO 9187- 2/AC

Injection equipment for medical use - Part 2: One-point-cut (OPC) ampoules

DS DS/EN ISO 9337- 1

Contact lenses - Determination of back vertex power - Part 1: Method using focimeter with manual focusing

DS DS/EN ISO 9337- 2

Contact lenses - Determination of back vertex power - Part 2: Measurement of contact lenses immersed in saline

DS DS/EN ISO 9338

Optics and optical instruments - Contact lenses - Determination of the diameters

DS DS/EN ISO 9339- 1

Optics and optical instruments - Contact lenses - Determination of the thickness - Part 1: Rigid contact lenses

DS DS/EN ISO 9339- 2

Optics and optical instruments - Contact lenses - Determination of thickness - Part 2: Hydrogel contact lenses

DS DS/EN ISO 9339- 2/AC

Optics and optical instruments - Contact lenses - Determination of thickness - Part 2: Hydrogel contact lenses

DS DS/EN ISO 9340

Optics and optical instruments - Contact lenses - Determination of strains for rigid contact lenses

DS DS/EN ISO 9341

Optics and optical instruments - Contact lenses - Determination of inclusions and surface imperfections for rigid contact lenses

DS DS/EN ISO 9342- 1

Optics and optical instruments Test lenses for calibration of focimeters Part 1: Test lenses for focimeters used for measuring spectacle lenses

DS DS/EN ISO 9360- 1

Anaesthetic and respiratory equipment - Heat and moisture exchangers (HMEs) for humidifying respired gases in humans - Part 1: HMEs for use with minimum tidal volumes of 250 ml

DS DS/EN ISO 9360- 2

Anaesthetic and respiratory equipment - Heat and moisture exchangers (HMEs) for humidifying respired gases in humans - Part 2: HMEs for use with tracheostomized patients having minimum tidal volumes of 250 ml

DS DS/EN ISO 9363- 1

Optics and optical instruments - Contact lenses - Determination of cytotoxicity of contact lens material - Part 1: Agar overlay test and growth inhibition test

DS DS/EN ISO 9394

Ophthalmic optics - Contact lenses and contact lens care products - Determination of biocompability by ocular study using rabbit eyes

DS DS/EN ISO 9626

Stainless steel needle tubing for the manufacture of medical devices

DS DS/EN ISO 9626/A1

Stainless steel needle tubing for manufacture of medical devices- (AMENDS DS/EN ISO 9626)

DS DS/EN ISO 9680

Dental operating light

DS DS/EN ISO 9687

Dental equipment - Graphical symbols

DS DS/EN ISO 9693

Metal-ceramic dental restorative systems

DS DS/EN ISO 9694

Dental phosphate-bonded casting investments

DS DS/EN ISO 9703- 3

Anaesthesia and respiratory care alarm signals - Part 3: Guidance on application of alarms

DS DS/EN ISO 9713

Neurosurgical implants - Self-closing intracranial aneurysm clips

DS DS/EN ISO 9801

Ophthalmic instruments - Trial case lenses

DS DS/EN ISO 9873

Dental hand instruments - Reusable mirrors and handles

DS DS/EN ISO 9913- 1

Optics and optical instruments - Contact lenses - Part 1: Determination of oxygen permeability and transmissibility by the FATT method

DS DS/EN ISO 9913- 2

Optics and optical instruments - Contact lenses - Part 2: Determination of oxygen permeability and transmissibility by the coulometric method

DS DS/EN ISO 9914

Optics and optical instruments - Contact lenses - Determination of refractive index of contact lens materials

DS DS/EN ISO 9917- 1

Dentistry - Water-based cements - Part 1: Powder/liquid acid-base cements

DS DS/EN ISO 9917- 2

Dental water-based cements - Part 2: Light-activated cements

DS DS/EN ISO 9919

Medical electrical equipment Particular requirements for the basic safety and essential performance of pulse oximeter equipment for medical use

DS DS/EN ISO 9997

Dental cartridge syringes

DS DS/EN ISO 9999

Technical aids for persons with disabilities - Classification and terminology

DS DS/ENV 12718

Medical compression hosiery

DS DS/ENV 12719

Medical thrombosis prophylaxis hosiery

DS DS/ENV 13004

Nomenclature system for medical devices for the purposes of regulatory data exchange - Recommendations for an interim system and rules for a future system

DS DS/ENV 14027

Method for the simulation of wear before the detection of nickel release from metal spectacle frames

DS DS/ENV 737- 6

Medical gas pipeline systems - Part 6: Dimensions and allocation of probes for terminal units for compressed medical gases and vacuum

DS DS/IEC 60601-2- 12

Medical electrical equipment - Part 2-12: Particular requirements for the safety of lung ventilators - Critical care ventilators

DS DS/IEC/TR 60788

Medical electrical equipment - Glossary of defined terms

DS DS/IEC/TR 60825- 8

Safety of laser products - Part 8: Guidelines for the safe use of medical laser equipment

DS DS/IEC/TR 60878

Graphical symbols for electrical equipment in medical practise

DS DS/IEC/TR 61010-3- 043

Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 3-043: Conformity verification report for IEC 61010-2-043:1997, Particular requirements for dry heat sterilizers using either hot air or hot inert gas for the

DS DS/IEC/TR 61010-3- 045

Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 3-045: Conformity verification report for IEC 61010- 2-045:2000 - Particular requirements for washer disinfectors used in medical, pharmaceutical, veterinary

DS DS/IEC/TR 61010-3- 101

Safety requirements for electrical equipment for measurement, control, and laboratory use Part 3-101: Conformity verification report for IEC 61010-2-101:2002 Particular requirements for in vitro diagnostic (IVD) medical equipment-(CD Rom)

DS DS/IEC/TR 61948- 1

Nuclear medicine instrumentation - Routine tests - Part 1: Radiation counting systems

DS DS/IEC/TR 61948- 2

Nuclear medicine instrumentation - Routine tests - Part 2: Scintillation cameras and single photon emission computed tomography imaging

DS DS/INF 139

Comparative analysis of system standards of the health care sector - DS/EN ISO 9001:2000 versus Joint Commission International Accreditation Standards for Hospitals (JCIA-SH:2000 - Requirements for organizations aiming for compliance with the unique JCIA

DS DS/ISO 10542- 1

Technical systems and aids for disabled or handicapped persons - Wheelchair tiedown and occupant-restraint systems - Part 1: Requirements and test methods for all systems

DS DS/ISO 10542- 2

Technical systems and aids for disabled or handicapped persons - Wheelchair tiedown and occupant-restraint systems - Part 2: Four-point strap-type tiedown systems

DS DS/ISO 10542- 3

Technical systems and aids for disabled or handicapped persons Wheelchair tiedown and occupant-restraint systems Part 3: Docking-type tiedown systems

DS DS/ISO 10542- 5

Technical systems and aids for disabled or handicapped persons - Wheelchair tiedown and occupant-restraint systems - Part 5: Systems for specific wheelchairs

DS DS/ISO 11140- 3

Sterilization of health care products - Chemical indicators - Part 3: Class 2 indicators for steam penetration test sheets

DS DS/ISO 11140- 4

Sterilization of health care products - Chemical indicators - Part 4: Class 2 indicators for steam penetration test packs

DS DS/ISO 11140- 5

Sterilization of health care products - Chemical indicators - Part 5: Class 2 indicators for air removal test sheets and packs

DS DS/ISO 11418- 1

Containers and accessories for pharmaceutical preparations Part 1: Drop-dispensing glass bottles

DS DS/ISO 11418- 2

Containers and accessories for pharmaceutical preparations Part 2: Screw-neck glass bottles for syrups

DS DS/ISO 11418- 3

Containers and accessories for pharmaceutical preparations Part 3: Screw-neck glass bottles (veral) for solid and liquid dosage forms

DS DS/ISO 11418- 4

Containers and accessories for pharmaceutical preparations Part 4: Tablet glass bottles

DS DS/ISO 11607

Packaging for terminally sterilized medical devices

DS DS/ISO 11737- 3

Sterilization of medical devices - Microbiological methods - Part 3: Guidance on the evaluation and interpretation of bioburden data

DS DS/ISO 12891- 2

Retrieval and analysis of surgical implants - Part 2: Analysis of retrieved metallic surgical implants

DS DS/ISO 12891- 3

Retrieval and analysis of surgical implants - Part 3: Analysis of retrieved polymeric surgical implants

DS DS/ISO 14969

Quality systems - Medical devices - Guidance on the application of ISO 13485 and ISO 13488

DS DS/ISO 14972

Sterile obturators for single use with over-needle peripheral intravascular catheters

DS DS/ISO 15190

Medical laboratories - Requirements for safety

DS DS/ISO 15198

Clinical laboratory medicine - In vitro diagnostic medical devices - Validation of user quality control procedures by the manufacturer

DS DS/ISO 15223

Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied-Amendment 1:11/07/2002; Amendment 2:06/15/2005

DS DS/ISO 15621

Urine-absorbing aids - Generel guidance on evaluation

DS DS/ISO 1563

Dentistry - Alginate dental impression material

DS DS/ISO 1566

Dental zinc phosphate cement

DS DS/ISO 15674

Cardiovascular implants and artificial organs - Hard-shell cardiotomy/venous reservoir systems (with/without filter) and soft venous reservoir bags

DS DS/ISO 15675

Cardiovascular implants and artificial organs - Cardiopulmonary bypass systems - Arterial line blood filters

DS DS/ISO 16037

Rubber condoms for clinical trials - Measurement of physical properties

DS DS/ISO 16038

Rubber condoms Guidance on the use of ISO 4074 in the quality management of natural rubber latex condoms

DS DS/ISO 16391

Aids for ostomy and incontinence - Irrigation sets - Requirements and test methods

DS DS/ISO 17190- 1

Urine-absorbing aids for incontinence - Test methods for characterizing polymer-based absorbent materials - Part 1: Determination of pH

DS DS/ISO 17190- 10

Urine-absorbing aids for incontinence - Test methods for characterizing polymer-based absorbent materials - Part 10: Determination of extractable polymer content by potentiometric titration

DS DS/ISO 17190- 11

Urine-absorbing aids for incontinence - Test methods for characterizing polymer-based absorbent materials - Part 11: Determination of content of respirable particles

DS DS/ISO 17190- 2

Urine-absorbing aids for incontinence - Test methods for characterizing polymer-based absorbent materials - Part 2: Determination of amount of residual monomers

DS DS/ISO 17190- 3

Urine-absorbing aids for incontinence - Test methods for characterizing polymer-based absorbent materials - Part 3: Determination of particle size distribution by sieve fractionation

DS DS/ISO 17190- 4

Urine-absorbing aids for incontinence - Test methods for characterizing polymer-based absorbent materials - Part 4: Determination of moisture content by mass loss upon heating

DS DS/ISO 17190- 5

Urine-absorbing aids for incontinence - Test methods for characterizing polymer-based absorbent materials - Part 5: Gravimetric determination of free swell capacity in saline solution

DS DS/ISO 17190- 6

Urine-absorbing aids for incontinence - Test methods for characterizing polymer-based absorbent materials - Part 6: Gravimetric determination of fluid retention capacity in saline solution after centrifugation

DS DS/ISO 17190- 7

Urine-absorbing aids for incontinence - Test methods for characterizing polymer-based absorbent materials - Part 7: Gravimetric determination of absorption under pressure

DS DS/ISO 17190- 8

Urine-absorbing aids for incontinence - Test methods for characterizing polymer-based absorbent materials - Part 8: Gravimetric determination of flowrate

DS DS/ISO 17190- 9+CORR.1

Urine-absorbing aids for incontinence - Test methods for characterizing polymer-based absorbent materials - Part 9: Gravimetric determination of density

DS DS/ISO 25539- 1

Cardiovascular implants - Endovascular devices - Part 1: Endovascular prostheses-Amendment 1: 11/22/2005

DS DS/ISO 3964

Dental handpieces - Coupling dimensions

DS DS/ISO 5361- 4

Tracheal tubes - Part 4: Cole type

DS DS/ISO 5837/2

Implants for surgery - Intramedullary nailing systems - Part 2: Medullary pins

DS DS/ISO 594- 1

Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment - Part 1: General requirements

DS DS/ISO 595- 1

Reusable all-glass or metal-and-glass syringes for medical use - Part 1: Dimensions

DS DS/ISO 595- 2

Reusable all-glass or metal-and-glass syringes for medical use - Part 2: Design, performance requirements and tests

DS DS/ISO 6871

Dental base metal casting alloys

DS DS/ISO 6874

Dentistry - Resin-based pit and fissure sealants

DS DS/ISO 7176- 1

Wheelchairs - Part 1: Determination of static stability

DS DS/ISO 7176- 10

Wheelchairs - Part 10: Determination of the obstacle-climbing ability of electric wheelchairs

DS DS/ISO 7176- 13

Wheelchairs - Part 13: Determination of coefficient of friction of test surfaces

DS DS/ISO 7176- 14

Wheelchairs - Part 14: Power and control systems for electric wheelchairs - Requirements and test methods

DS DS/ISO 7176- 15

Wheelchairs - Part 15: Requirements for information disclosure, documentation and labelling

DS DS/ISO 7176- 16

Wheelchairs - Part 16: Resistance to ignition of upholstered parts - Requirements and test methods

DS DS/ISO 7176- 19

Wheelchairs - Part 19: Wheeled mobility devices for use in motor vehicles

DS DS/ISO 7176- 2

Wheelchairs - Part 2: Determination of dynamic stability of electric wheelchairs

DS DS/ISO 7176- 21

Wheelchairs - Part 21: Requirements and test methods for electromagnetic compatibility of electrically powered wheelchairs and motorized scooters

DS DS/ISO 7176- 22

Wheelchairs - Part 22: Set-up procedures

DS DS/ISO 7176- 23

Wheelchairs - Part 23: Requirements and test methods for attendant- operated stair-climbing devices

DS DS/ISO 7176- 3

Wheelchairs - Part 3: Determination of effectiveness of brakes

DS DS/ISO 7176- 4

Wheelchairs - Part 4: Energy consumption of electric wheelchairs and scooters for determination of theoretical distance range

DS DS/ISO 7176- 5

Wheelchairs - Part 5: Determination of overall dimensions, mass and turning space

DS DS/ISO 7176- 6

Wheelchairs - Part 6: Determination of maximum speed, acceleration and deceleration of electric wheelchairs

DS DS/ISO 7176- 7

Wheelchairs - Part 7: Measurement of seating and wheel dimensions

DS DS/ISO 7176- 8

Wheelchairs - Part 8: Requirements and test methods for static, impact and fatigue strengths

DS DS/ISO 7176- 9

Wheelchairs - Part 9: Climatic tests for electric wheelchairs

DS DS/ISO 7787- 1

Dental rotary instruments - Cutters - Part 1: Steel laboratory cutters

DS DS/ISO 7864

Sterile hypodermic needles for single use

DS DS/ISO 8382

Resuscitators intended for use with humans

DS DS/ISO 8669- 1

Urine collection bags - Part 1: Vocabulary

DS DS/ISO 8670- 1

Ostomy collection bags - Part 1: Vocabulary

DS DS/ISO 8670- 3

Ostomy collection bags - Part 3: Determination of odour transmission of colostomy and ileostomy bags

DS DS/ISO/PAS 18873

International protocol for doping control

DS DS/ISO/TR 11548- 1

Communication aids for blind persons - Identifiers, names and assignation to coded character sets for 8-dot Braille characters - Part 1: General guidelines for Braille identifiers and shift marks

DS DS/ISO/TR 11548- 2

Communication aids for blind persons - Identifiers, names and assignation to coded character sets for 8-dot Braille characters - Part 2: Latin alphabet based character sets

DS DS/ISO/TR 13570- 1

Wheelchairs Part 1: Guidelines for the application of the ISO 7176 series on wheelchairs-:2002

DS DS/ISO/TR 15844

Sterilization of health care products - Radiation sterilization - Selection of a sterilization dose for a single production batch

DS DS/ISO/TR 16142

Medical devices - Guidance on the selection of standards in support of recognized essential principles of safety and performance of medical devices

DS DS/ISO/TR 22869

Medical laboratories Guidance on laboratory implementation of ISO 15189:2003

DS DS/ISO/TS 13409

Sterilization of health care products - Radiation sterilization - Substantiation of 25 kGy as a sterilization dose for small or infrequent production batches

DS DS/ISO/TS 15539

Cardiovascular implants - Endovascular prostheses

DS DS/ISO/TS 15843

Sterilization of healthcare products - Radiation sterilization - Product families and sampling plans for verification dose experiments and sterilization dose audits, and frequency of sterilization dose audits

DS DS/ISO/TS 16071

Ergonomics of human-system interaction - Guidance on accessibility for human-computer interfaces

DS DS/ISO/TS 16628

Tracheobronchial tubes - Recommendations for size designation and labelling

DS DS/ISO/TS 19218

Medical devices Coding structure for adverse event type and cause

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