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СтандартыBSI

BS ISO 23409:2011

Действует
Male condoms. Requirements and test methods for condoms made from synthetic materials — 54 стр.
ОписаниеИзмененияСсылкиВерсии

Ссылочные документы

ISO 4074:2002
Заменен
Natural latex rubber condoms. Requirements and test methods — 52 стр.
ISO/TR 8550-1:2007
Действует
Guidance on the selection and usage of acceptance sampling systems for inspection of discrete items in lots -- Part 1: Acceptance sampling — 46 стр.
ISO 2859-1:1999/Amd.1:2011
Действует
Sampling procedures for inspection by attributes -- Part 1: Sampling schemes indexed by acceptance quality limit (AQL) for lot-by-lot inspection -- Amendment 1 — 8 стр.
ISO 10993-1:2009
Заменен
Biological evaluation of medical devices -- Part 1: Evaluation and testing within a risk management process — 28 стр.
ISO 10993-5:2009
Действует
Biological evaluation of medical devices -- Part 5: Tests for in vitro cytotoxicity — 42 стр.
ISO 14971:2007
Действует
Medical devices -- Application of risk management to medical devices — 90 стр.
BS ISO 15223-2:2010
Действует
Medical devices. Symbols to be used with medical device labels, labelling, and information to be supplied. Symbol development, selection and validation — 28 стр.
ISO 9004:2018
Действует
Quality management -- Quality of an organization -- Guidance to achieve sustained success — 68 стр.
ISO 10993-11:2006
Заменен
Biological evaluation of medical devices -- Part 11: Tests for systemic toxicity — 34 стр.
BS ISO 11346:2014
Действует
Rubber, vulcanized or thermoplastic. Estimation of life-time and maximum temperature of use — 20 стр.
BS ISO 29943-1:2017
Действует
Condoms. Guidance on clinical studies. Male condoms, clinical function studies based on self-reports — 50 стр.
ISO 10993-10:2010
Действует
Biological evaluation of medical devices -- Part 10: Tests for irritation and skin sensitization — 74 стр.
ISO 14155:2011
Действует
Clinical investigation of medical devices for human subjects -- Good clinical practice — 66 стр.
ISO 16037:2002/Amd.1:2011
Действует
Rubber condoms for clinical trials -- Measurement of physical properties – Amendment 1 — 6 стр.
BS ISO 18899:2013
Действует
Rubber. Guide to the calibration of test equipment — 26 стр.
BS ISO 22309:2011
Действует
Microbeam analysis. Quantitative analysis using energy-dispersive spectrometry (EDS) for elements with an atomic number of 11 (Na) or above — 32 стр.
ISO 9001:2015
Действует
Quality management systems -- Requirements — 40 стр.
ISO 13485:2003
Заменен
Medical devices -- Quality management systems -- Requirements for regulatory purposes — 64 стр.
BS ISO 16038:2005
Заменен
Rubber condoms. Guidance on the use of ISO 4074 in the quality management of natural rubber latex condoms — 20 стр.
ISO/IEC Guide 71:2014
Действует
Guide for addressing accessibility in standards — 56 стр.
BS EN 980:2008
Заменен
Symbols for use in the labelling of medical devices — 38 стр.
ASTM D3078-02
Заменен
Standard Test Method for Determination of Leaks in Flexible Packaging by Bubble Emission — 3 стр.
ASTM D3767-03
Заменен
Standard Practice for Rubber-Measurement of Dimensions — 8 стр.
ISO/IEC 17025:2017
Действует
General requirements for the competence of testing and calibration laboratories — 38 стр.

На этот документ ссылаются

PD ISO/TR 19969:2018
Действует
Guidance on sample handling for determination of bursting volume and pressure, and testing for freedom from holes for male condom — 18 стр.
BS ISO 19671:2018
Действует
Additional lubricants for male natural rubber latex condoms. Effect on condom strength — 24 стр.