| ISO R594 |
Conical fittings for syringes, needles and other
medical equipment |
| ISO 594/1 |
Conical fittings with a 6% (Luer) taper for syringes, needles and other
medical equipment-- Part 1: General requirements |
| ISO 594-2 |
Conical fittings with a 6% (Luer) taper for syringes, needles and other
medical equipment-- Part 2: Lock fittings |
| ISO 780 |
Packaging-Pictorial marking for handling of goods |
| ISO 1219 |
Fluid power systems and components-Graphic symbols |
| ISO 1797-1: 1992 |
Dental rotary instruments--Shanks
Part 1: Shanks made of metals |
| ISO 2859-0 |
Sampling procedures for inspection by attributes Part 0: Introduction to the ISO 2859 attribute sampling system |
| ISO 2859-1 |
Sampling procedures for inspection by attributes Part 1: Sampling schemes indexed by acceptance quality limit (AQL) for lot-by-lot inspection |
| ISO 2859-2 |
Sampling procedures for inspection by attributes Part 2: Sampling plans indexed by limiting quality (LQ) for isolated lot inspection |
| ISO 2859-3 |
Sampling procedures for inspection by attributes Part 3: Skip-lot sampling procedures |
| ISO 2859-4 |
Sampling procedures for inspection by attributes Part 4: Procedures for assessment of stated quality levels |
| ISO 3040 |
Technical drawings--Dimensioning and tolerancing--
Cones |
| ISO 3696 |
Water for analytical laboratory
use--Specification and test methods |
| ISO 3746 |
Acoustics-Determination of sound power levels of noise sources using sound |
| ISO 3964 |
Dental handpieces - Coupling dimensions |
| ISO 5356-1 |
Anesthetic and respiratory equipment-Conical connectors Part 1: cones and sockets |
| ISO 5367 |
Breathing tubes intended for use with
anaesthetic apparatus and ventilators |
| ISO 5457 |
Technical drawings-Sizes and layout of drawing sheets |
| ISO 5725-2 |
Accuracy of measurement methods and results,
Part 2: Basic method for the determination of repeatability and
reproducibility of a standard measurement method |
| ISO 5941 |
Compressors, pneumatic tools and
machines--Preferred pressures |
| ISO 6009 |
Hypodermic needles for single use--Color coding for identification |
| ISO 6360-1 |
Dental rotary instruments- Number coding system Part 1: General characteristics |
| ISO 6440 |
Wheelchairs-Nomenclature, terms and definitions |
| ISO 6710 |
Single-use containers for venous blood specimen
collection |
| ISO 7000 |
Graphical symbols for use on equipment-Index and synopsis |
| ISO 7176-1 |
Wheelchairs-- Part 1: Determination of static stability |
| ISO 7176-2 |
Wheelchairs-- Part 2: Determination of dynamic stability of electric wheelchairs |
| ISO 7176-3 |
Wheelchairs-- Part 3: Determination of efficiency of brakes |
| ISO 7176-4 |
Wheelchairs-- Part 4: Energy consumption of electric wheelchairs and scooters for determination of theoretical distance range |
| ISO 7176-5 |
Wheelchairs-- Part 5: Determination of overall dimensions, mass and turning space |
| ISO 7176-6 |
Wheelchairs-- Part 6: Determination of maximum speed, acceleration and retardation of electric wheelchairs |
| ISO 7176-7 |
Wheelchairs-- Part 7: Measurement of seating and wheel dimensions |
| ISO 7176-8 |
Wheelchairs-- Part 8: Requirements and test methods for static, impact and fatigue strengths |
| ISO 7176-9 |
Wheelchairs-- Part 9: Climatic tests for electric wheelchairs |
| ISO 7176-10 |
Wheelchairs-- Part 10: Determination of obstacle-climbing ability of electric wheelchairs |
| ISO 7176-11 |
Wheelchairs-- Part 10: Determination of obstacle-climbing ability of electric wheelchairs |
| ISO 7176-13 |
Wheelchairs--Part 13: Determination of coefficient of friction of test surfaces |
| ISO 7176-14 |
Wheelchairs--Part 14: Power and control systems for electric wheelchairs- Requirements and test methods |
| ISO 7176-15 |
Wheelchairs-- Part 15: Requirements for information disclosure, documentation and
libeling |
| ISO 7176-16 |
Wheelchairs-- Part 16: Resistance to ignition of upholstered parts-- Requirements and test methods |
| ISO 7176-19 |
Wheelchairs-- Part 19: Wheeled mobility devices
for use in motor vehicles |
| ISO 7176-22 |
Wheelchairs-- Part 22: Set-up procedures |
| ISO 7176-23 |
Wheelchairs-- Part 23: Requirements and test
methods for attendant-operated stair-climbing devices |
| ISO 7376-1 |
Laryngoscopic fittings-- Part 1: Conventional
hook-on type handle-blade fittings |
| ISO 7376-2 |
Laryngoscopic fittings-- Part 2: Miniature
electric lamps--Screw threads and sockets for conventional blades |
| ISO 7376-3 |
Laryngoscopic fittings-- Part 3: Fiber-illuminated
re-usable rigid laryngoscopes |
| ISO 7193 |
Wheelchairs-Maximum overall dimensions |
| ISO 7711-1 |
Dental rotary instruments- Diamond instruments Part 1: Dimensions, requirements, marking and packaging |
| ISO 7864 |
Sterile hypodermic needles for single use |
| ISO 7785-1: 1997 |
Dental handpieces-- Part 1: High-speed air
turbine handpieces |
| ISO 7785-2 |
Dental handpieces-- Part 2: Straight and geared
angle handpieces |
| ISO 7886-1 |
Sterile hypodermic needles for single use Part 1: Syringes for manual use |
| ISO 7886-2 |
Sterile hypodermic needles for single use Part 2: Syringes for use with power-driven syringe pumps |
| ISO 7930 |
Wheelchairs--Type classification based on appearance
characteristics |
| ISO 8320 |
Optics and optical instruments--contact lenses--vocabulary and symbols |
| ISO 8320-1 |
Contact lenses and conact lens care
products--Vocabulary Part 1: Contact lenses |
| ISO 8320-2 |
Contact lenses and conact lens care
products--Vocabulary Part 2: Contact lens care products |
| ISO 8321-1 |
Optics and optical instruments--contact lenses Part 1: specification for rigid corneal and
sclera contact lenses |
| ISO 8321-2 |
Optics and optical instruments--contact lenses Part 2: Specifications for single-vision
hydrogen contact lenses |
| ISO 8382 |
Resuscitators intended for use with humans |
| ISO 8536-1 |
Infusion equipment for medical use-- Part 1 :
Infusion glass bottles |
| ISO 8536-2 |
Infusion equipment for medical use-- Part 2 :
Closures for infusion bottles |
| ISO 8536-3 |
Infusion equipment for medical use-- Part 3 :
Aluminium caps for infusion bottles |
| ISO 8536-4 |
Infusion equipment for medical use-- Part 4 :
Infusion sets for single use, gravity feed |
| ISO 8536-5 |
Infusion equipment for medical use-- Part 5 :
Burette type infusion sets |
| ISO 8536-6 |
Infusion equipment for medical use-- Part 6 :
Freeze drying closures for infusion bottles |
| ISO 8536-7 |
Infusion equipment for medical use-- Part 7 :
Caps made of aluminium--plastics combinations for infusion bottles |
| ISO 8537 |
Sterile single-use syringes, with or without needle, for insulin |
| ISO 8599 |
Optics and optical instruments--Contact lenses-Determination of the spectral and luminous transmittance |
| ISO 8601 |
Data elements and interchange formats--Information interchange--representation of dates and times |
| ISO 8980-1 |
Ophthalmic optics--finished single-vision corrective lenses-- Part 1: General requirements |
| ISO 8980-2 |
Ophthalmic optics-- Uncut finished spectacle lenses Part 2: Specifications for progressive power lenses |
| ISO 9000 |
Quality management systems- Fundamentals and
vocabulary |
| ISO 9000-4 |
Quality management and quality assurance
standards- |
| ISO 9001 |
Quality management systems- Requirements |
| ISO 9004 |
Quality management systems - Guidelines for performance improvements |
| ISO 9004-1 |
Quality management and quality system elements-- Part 1: Guidelines |
| ISO 9004-2 |
Quality management and quality system elements-- Part
2: Guidelines for services |
| ISO 9004-3 |
Quality management and quality system elements-- Part 3: Guidelines for processed materials |
| ISO 9004-4 |
Quality management and quality system elements-- Part 4: Guidelines for quality improvement |
| ISO 9168: 1991 |
Dental handpieces-- Hose connectors |
| ISO 9336-1 |
Optics and optical instruments--Optical transfer function--application Part 1: Interchangeable lenses for 35mm still cameras |
| ISO 9336-2 |
Optics and optical instruments--Optical transfer function--application Part 2: Lenses for office copiers |
| ISO 9336-3 |
Optics and optical instruments--Optical transfer function--application Part 3: Telescopes |
| ISO 9338 |
Optics and optical instruments-contact lenses-determination of the diameters |
| ISO 9339-1 |
Optics and optical instruments-contact lenses-determination of the thickness Part 1: rigid contact lenses |
| ISO 9340 |
Optics and optical instruments-contact lenses-determination of strains for rigid contact lenses |
| ISO 9341 |
Optics and optical instruments-contact lenses-determination of inclusions and surface imperfections for rigid contact lenses |
| ISO 9342 |
Optics and optical instruments--Test lenses for calibration of
foci meters |
| 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 250ml |
| 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 250ml |
| ISO 9363-1 |
Optics and optical instruments--Contact lenses- Determination of cytotoxicity of contact lens material |
| ISO 9614-1 |
Acoustics-Determination of sound power levels of noise sources using sound.
Part 1: Measurement at discrete points |
| ISO 9626 |
Stainless steel needle tubing for manufacture of medical devices |
| ISO 9680 |
Dental operating light |
| ISO 9687 |
Dental equipment-- Graphical symbols |
| ISO 9913-1 |
Optics and optical instruments- contact lenses Part 1: Determination of oxygen permeability and
transmissibility by the FATT method |
| ISO 9914 |
Optics and optical instruments- contact lenses-- Determination of refractive index of contact lens materials |
| ISO 9919 |
Medical electrical equipment--Particular
requirements for the basic safety and essential performance pulse oximeters
requirement for medical use |
| ISO 9999 |
Technical aids for disabled persons Classification |
| ISO 10005 |
Quality management- Guidelines for quality plans |
| ISO 10006 |
Quality management- Guidelines to quality in project management |
| ISO 10007 |
Quality management- Guidelines for configuration management |
| ISO 10012-1 |
Quality assurance requirements for measuring equipment Part 1: Metrological confirmation system for measuring equipment |
| ISO 10012-2 |
Quality assurance requirements for measuring equipment Part 2: Guidelines for control of measurement processes |
| ISO 10013 |
Guidelines for developing quality manuals |
| ISO 10014 |
Guidelines for managing the economics of quality |
| ISO 10015 |
Quality management- Guidelines for training |
| ISO 10017 |
Guidance on statistical techniques for ISO
9001:1994 |
| ISO 10079-1 |
Medical suction equipment Part 1: electrically powered suction equipment--Safety requirements |
| ISO 10079-2 |
Medical suction equipment Part 2: Manually powered suction equipment |
| ISO 10079-3 |
Medical suction equipment Part 3: Suction equipment powered from vacuum or pressure source |
| ISO 10338 |
Optics and optical instruments- contact lenses- determination of curvature |
| ISO 10339 |
Ophthalmic optics--contact lenses--Determination of water content of hydrogel lenses |
| ISO 10322-1 |
Ophthalmic optics--Semi-finished lens blanks Part 1: specifications for single-vision and multifocal lens blanks |
| ISO 10340 |
Optics and optical instruments- contact lenses-- Method for determining the extractable substances |
| ISO 10344 |
Optics and optical instruments- contact lenses- saline solution for contact lens testing |
| ISO 10555-1:1995 |
Sterile, single use Intravascular Catheters;
Part 1: General requirements |
| ISO 10555-1:2009 |
Sterile, single use Intravascular Catheters;
Part 1: General requirements |
| ISO 10555-2:1996 |
Sterile, single use Intravascular Catheters;
Part 2: Angiographic catheters |
| ISO 10555-3:1996 |
Sterile, single use Intravascular Catheters;
Part 3: Central venous catheters |
| ISO 10555-4:1996 |
Sterile, single use Intravascular Catheters;
Part 3: Balloon dilatation catheters |
| ISO 10555-5:1996 |
Sterile, single use Intravascular Catheters;
Part 3: Over-needle peripheral catheters |
| ISO 10725 |
General requirements for the competence of
testing and calibration laboratories |
| ISO 10993-1 |
Biological evaluation of medical devices- Part 1: evaluation and testing |
| ISO 10993-3 |
Biological evaluation of medical devices- Part
3: test for genotoxicity carcinogenicity and reproductive toxicity |
| ISO 10993-4 |
Biological evaluation of medical devices- Part
4: Selection of tests for interactions with blood. |
| ISO 10993-5 |
Biological evaluation of medical devices- Part
5: test for in vitro cytotoxicity |
| ISO 10993-7 |
Biological evaluation of medical devices- Part
7: Ethylene oxide sterilization residuals |
| ISO 10993-10 |
Biological evaluation of medical devices- Part
10: Tests for irritation and delayed-type hypersensitivity |
| ISO 10993-11 |
Biological evaluation of medical devices- Part
11: Tests for systemic toxicity |
| ISO 11134 |
Sterilization of health care
products--Requirements for validation and routine control-- Industrial moist
heat sterilization |
| ISO 11135 |
Medical devices--Validation and routine control of ethylene oxide sterilization |
| ISO 11137 |
Sterilization of health care products--Requirements for validation and routine control--Radiation sterilization |
| ISO 11137-1: 2006 |
Sterilization of health care products--Requirements for validation and routine control--Radiation sterilization |
| ISO 11137-2: 2006 |
Sterilization of health care products--Radiation--Establishing
the sterilization dose |
| ISO 11137-3: 2006 |
Sterilization of health care products--Radiation--
Guidance for dosimetric aspects |
| ISO 11199-1 |
Walking aids manipulated by both arms--
Requirements and test methods--- Part 1:
Walking frames |
| ISO 11199-2 |
Walking aids manipulated by both arms--
Requirements and test methods--- Part 2: Rollator |
| ISO 11987 |
Ophthalmic optics--contact lenses--Determination of shelf-life |
| ISO 12864 |
Ophthalmic optics-- contact lenses- determination of scattered light |
| ISO 13402 |
Surgical and dental hand
instruments--Determination of resistance against autoclaving, corrosion and
thermal exposure |
| ISO 13485 |
Quality systems- Medical devices- Particular requirements for the application of ISO 9001 |
| ISO13485
( 2000 : Draft ) |
Quality management systems- Medical devices-
System requirements for regulatory purposes |
| ISO13485
( 2003/07/15 ) |
Medical devices--Quality management
systems--Requirements for regulatory purposes |
| ISO 14001 |
Environmental management systems--Specification with guidance for use |
| ISO 14155 |
Clinical investigation of medical devices |
| ISO 14457: 2017 |
Dentistry--Handpieces and motors |
| ISO 14534 |
Ophthalmic optics-Contact lenses and contact lens care products-fundamental requirements |
| ISO 14602 |
Non-active surgical implants---Implants for Osteosynthesis Particular requirements |
| ISO 14630 |
Non-active surgical implants---General requirements |
| ISO 14889 |
Ophthalmic optics-Spectacle lenses-Fundamental requirements for uncut finished lenses |
| ISO 14969 |
Quality systems-Medical devices- Guidance on the application of ISO 13485 and ISO 13488 |
| ISO 14971: 2003 |
Medical devices---Application of risk management
to medical devices |
| ISO 14971: 2007 |
Medical devices---Application of risk management
to medical devices |
| ISO 14971: 2019 |
Medical devices---Application of risk management
to medical devices |
| ISO 15197 |
In vitro diagnostic test systems-- Requirements
for blood-glucose monitoring systems for self-testing in managing diabetes
mellitus |
| ISO 15223-1: 2008 |
Medical devices-- Symbols to be used with
medical device labels, labeling and information to be supplied |
| ISO 15223-1: 2016 |
Medical devices-- Symbols to be used with
medical device labels, labeling and information to be supplied |
| ISO 15606: 1999 |
Dental handpieces-- Air-powered scalers and
scaler tips |
| ISO / TS 16949 |
Particular requirements for the application of
ISO 9001: 2000 for automotive production and relevant service part
organizations |
| ISO 17025 |
General requirements for the competence of
testing and calibration laboratories |
| ISO 17511 |
In vitro diagnostic medical devices--
Measurement of quantities in biological samples -- Metrological traceability
of values assigned to calibrators and control materials |
| ISO 17664 |
Sterilization of medical devices-- Information
to be provided by the manufacturer for the processing of resterilizable
medical devices |
| ISO 17665-1 |
Sterilization of health care products-- part 1:
validation and control of sterilization process for
medical devices |
| ISO 17799 |
Information technology-Code of practice for information security management |
| ISO 19011 |
Guidelines for quality and/or environmental
management systems auditing |
| ISO 20225:2001
(GMDN) |
Global Medical Device Nomenclature for the
purpose of regulatory data exchange |
| ISO 21647 |
Medical electrical equipment--Particular
requirements for the basic safety and essential performance of respiratory
gas monitors |
| ISO 22000 |
Food safety management systems-- Requirements
for any organization in the food chain |
| ISO 22716 |
Cosmetics-- Guideline on Good Manufacturing
Practices |
| ISO TR 24971: 2020 |
Medical devices — Guidance on the application of
ISO 14971 |
| ISO 27001 |
Internal Information Security Management System |
