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Standards [CURRENT]

BS EN 868-9

Packaging for terminally sterilized medical devices. Uncoated nonwoven materials of polyolefines. Requirements and test methods
Edition 2019-01-09

Standards [CURRENT]

BS EN 868-6

Packaging for terminally sterilized medical devices. Paper for low temperature sterilization processes. Requirements and test methods
Edition 2017-02-28

Standards [CURRENT]

PD IEC/TR 80001-2-3

Application of risk management for IT-networks incorporating medical devices. Guidance for wireless networks
Edition 2012-10-31

Standards [CURRENT]

BS EN ISO 22442-3

Medical devices utilizing animal tissues and their derivatives. Validation of the elimination and/or inactivation of viruses and transmissible spongiform encephalopathy (TSE) agents
Edition 2008-02-29

Standards [CURRENT]

BS EN ISO 11137-1+A2

Sterilization of health care products. Radiation. Requirements for development, validation and routine control of a sterilization process for medical devices
Edition 2015-07-31

Biological evaluation of medical devices - Part 19: physico-chemical, morphological and topographical characterization of materials
Edition 2022-06-15

Biological evaluation of medical devices - Part 7: ethylene oxide sterilization residuals
Edition 2008-12-01

Biological evaluation of medical devices - Part 12: sample preparation and reference materials
Edition 2021-06-16

Biological evaluation of medical devices - Part 7: ethylene oxide sterilization residuals - Amendment 1 : applicability of allowable limits for neonates and infants
Edition 2022-01-12

Biological evaluation of medical devices - Part 17: toxicological risk assessment of medical device constituents
Edition 2023-11-22

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