New VDA 4: 2020, English version 2021 is avilable here.

 

Homepage>BS Standards>11 HEALTH CARE TECHNOLOGY>11.100 Laboratory medicine>11.100.20 Biological evaluation of medical devices

11.100.20 Biological evaluation of medical devices

CURRENCY
PRICES include / exclude VAT
Price include VAT will be charged for customers of European Union – non VAT payers.
Price exclude VAT will be charged for customers of European Union – VAT payers (with valid EU VAT number) and for customers outside of European Union.
immediate download
Released: 2009-07-31
BS EN ISO 10993-15:2009
Biological evaluation of medical devices Identification and quantification of degradation products from metals and alloys
LANGUAGE
English
immediate download
Released: 2020-03-30
BS EN ISO 10993-16:2017
Biological evaluation of medical devices Toxicokinetic study design for degradation products and leachables
LANGUAGE
English
immediate download
Released: 2009-06-30
BS EN ISO 10993-17:2009
Biological evaluation of medical devices Establishment of allowable limits for leachable substances
LANGUAGE
English
immediate download
Released: 2020-12-14
BS EN ISO 10993-18:2020
Biological evaluation of medical devices Chemical characterization of medical device materials within a risk management process
LANGUAGE
English
immediate download
Released: 2020-12-21
BS EN ISO 10993-1:2020 - TC
Tracked Changes. Biological evaluation of medical devices Evaluation and testing within a risk management process
LANGUAGE
English
immediate download
Released: 2020-12-16
BS EN ISO 10993-1:2020
Biological evaluation of medical devices Evaluation and testing within a risk management process
LANGUAGE
English
immediate download
Released: 2021-04-09
BS EN ISO 10993-23:2021
Biological evaluation of medical devices Tests for irritation
LANGUAGE
English
immediate download
Released: 2006-09-29
BS EN ISO 10993-2:2006
Biological evaluation of medical devices Animal welfare requirements
LANGUAGE
English
immediate download
Released: 2014-10-31
BS EN ISO 10993-3:2014
Biological evaluation of medical devices Tests for genotoxicity, carcinogenicity and reproductive toxicity
LANGUAGE
English
immediate download
Released: 2017-05-25
BS EN ISO 10993-4:2017
Biological evaluation of medical devices Selection of tests for interactions with blood
LANGUAGE
English
immediate download
Released: 2009-07-31
BS EN ISO 10993-5:2009
Biological evaluation of medical devices Tests for in vitro cytotoxicity
LANGUAGE
English
immediate download
Released: 2020-02-24
BS EN ISO 10993-6:2016 - TC
Tracked Changes. Biological evaluation of medical devices Tests for local effects after implantation
LANGUAGE
English