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ISO 6507-1:2005
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Metallic materials Vickers hardness test Part 1: Test method
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ISO 11137-1:2006
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Sterilization of health care products Radiation Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
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ISO 10282:2014
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Single-use sterile rubber surgical gloves — Specification
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ISO 11607-2:2006
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Packaging for terminally sterilized medical devices Part 2: Validation requirements for forming, sealing and assembly processes
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ISO 6507-4:2005
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Metallic materials Vickers hardness test Part 4: Tables of hardness values
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ISO 15223-2:2010
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Medical devices — Symbols to be used with medical device labels, labelling, and information to be supplied — Part 2: Symbol development, selection and validation
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ISO 15510:2014
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Stainless steels Chemical composition
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ISO 9626:2016
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Stainless steel needle tubing for the manufacture of medical devices — Requirements and test methods
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ISO 11737-2:2009
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Sterilization of medical devices Microbiological methods Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process
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ISO 11737-1:2006
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Sterilization of medical devices Microbiological methods Part 1: Determination of a population of microorganisms on products
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ISO 6507-2:2005
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Metallic materials Vickers hardness test Part 2: Verification and calibration of testing machines
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2007/47/EC : 2007 COR 1 2015
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DIRECTIVE 2007/47/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL OF 5 SEPTEMBER 2007 AMENDING COUNCIL DIRECTIVE 1990/385/EEC ON THE APPROXIMATION OF THE LAWS OF THE MEMBER STATES RELATING TO ACTIVE IMPLANTABLE MEDICAL DEVICES, COUNCIL DIRECTIVE 1993/42/EEC CONCERNING MEDICAL DEVICES AND DIRECTIVE 1998/8/EC CONCERNING THE PLACING OF BIOCIDAL PRODUCTS ON THE MARKET(TEXT WITH EEA RELEVANCE)
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ISO 13485:2016
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Medical devices Quality management systems Requirements for regulatory purposes
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ISO 6507-3:2005
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Metallic materials Vickers hardness test Part 3: Calibration of reference blocks
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ISO 11138-2:2017
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Sterilization of health care products — Biological indicators — Part 2: Biological indicators for ethylene oxide sterilization processes
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ISO 11135-1:2007
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Sterilization of health care products Ethylene oxide Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
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EN 1041:2008+A1:2013
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Information supplied by the manufacturer of medical devices
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SAC GB 2024 : 1994
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ACUPUNCTURE NEEDLES
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ISO 10993-10:2010
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Biological evaluation of medical devices Part 10: Tests for irritation and skin sensitization
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ISO 780:2015
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Packaging Distribution packaging Graphical symbols for handling and storage of packages
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ISO 10993-11:2017
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Biological evaluation of medical devices — Part 11: Tests for systemic toxicity
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SAC GB/T 1031 : 1995
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GEOMETRICAL PRODUCT SPECIFICATIONS (GPS) - SURFACE TEXTURE: PROFILE METHOD - SURFACE ROUGHNESS PARAMETERS AND THEIR VALUES
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ISO 10993-7:2008
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Biological evaluation of medical devices Part 7: Ethylene oxide sterilization residuals
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ISO 11137-2:2013
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Sterilization of health care products — Radiation — Part 2: Establishing the sterilization dose
|
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ISO 7864:2016
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Sterile hypodermic needles for single use — Requirements and test methods
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ISO 10993-1:2009
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Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
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ISO 3696:1987
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Water for analytical laboratory use — Specification and test methods
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ISO 11138-1:2017
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Sterilization of health care products — Biological indicators — Part 1: General requirements
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ISO 14971:2007
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Medical devices Application of risk management to medical devices
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ISO 7000:2014
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Graphical symbols for use on equipment Registered symbols
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ISO 11607-1:2006
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Packaging for terminally sterilized medical devices Part 1: Requirements for materials, sterile barrier systems and packaging systems
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|
ISO 15223-1:2016
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Medical devices Symbols to be used with medical device labels, labelling and information to be supplied Part 1: General requirements
|
|
EN 980:2008
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Symbols for use in the labelling of medical devices
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|
ISO 17665-1:2006
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Sterilization of health care products — Moist heat — Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices
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EN 10088-1:2014
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Stainless steels - Part 1: List of stainless steels
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