iso 13485 version 2016 pdf free download

ISO 5356-1:2015 Anaesthetic and respiratory equipment - Conical connectors - Part 1: Cones and sockets.

ISO 20395:2019 Biotechnology - Requirements for evaluating the performance of quantification methods for nucleic acid target sequences - qPCR and dPCR.

ISO 19223:2019 Lung ventilators and related equipment - Vocabulary and semantics.ISO 18562-4:2017 Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 4: Tests for leachables in condensate.ISO 18562-3:2017 Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 3: Tests for emissions of volatile organic compounds (VOCs).ISO 18562-2:2017 Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 2: Tests for emissions of particulate matter.

ISO 18562-1:2017 Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 1: Evaluation and testing within a risk management process.

ISO 18082:2014 Anaesthetic and respiratory equipment - Dimensions of non-interchangeable screw-threaded (NIST) low-pressure connectors for medical gases (Including ISO 18082:2014/AMD 1:2017, AMENDMENT 1).

ISO 17510:2015 Medical devices - Sleep apnoea breathing therapy - Masks and application accessories.

ISO 13688:2013 Protective clothing – General requirements.

ISO 10993-1:2018 Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process.

ISO 10651-5:2006 Lung ventilators for medical use - Particular requirements for basic safety and essential performance - Part 5: Gas-powered emergency resuscitators.

ISO 10651-4:2002 Lung ventilators - Part 4: Particular requirements for operator-powered resuscitators.

ISO 10651-3:1997 Lung ventilators for medical use - Part 3: Particular requirements for emergency and transport ventilators.

ISO 374-5:2016 Protective gloves against dangerous chemicals and micro-organisms – Part 5: Terminology and performance requirements for micro-organisms risk.ISO 13485:2016 Medical devices - Quality management systems – Requirements for regulatory purposes.The following ISO standards are available in read-only text format:

Iso 13485 version 2016 pdf free download