NA 063

DIN Standards Committee Medicine

DIN EN ISO 4074 [CURRENT] references following documents:

Document number Edition Title
ISO 10993-5 2009-06 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity More 
ISO 15223-2 2010-01 Medical devices - Symbols to be used with medical device labels, labelling, and information to be supplied - Part 2: Symbol development, selection and validation More 
ISO 2859-1 1999-11 Sampling procedures for inspection by attributes - Part 1: Sampling schemes indexed by acceptance quality limit (AQL) for lot-by-lot inspection More 
ASTM D 3492 2016 Standard Specification for Rubber Contraceptives (Male Condoms) More 
DIN EN ISO 10993-10 2014-10 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization (ISO 10993-10:2010); German version EN ISO 10993-10:2013 More 
DIN EN ISO 10993-5 2009-10 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity (ISO 10993-5:2009); German version EN ISO 10993-5:2009 More 
DIN EN ISO 9000 2015-11 Quality management systems - Fundamentals and vocabulary (ISO 9000:2015); German and English version EN ISO 9000:2015 More 
DIN ISO 2859-1 2014-08 Sampling procedures for inspection by attributes - Part 1: Sampling schemes indexed by acceptance quality limit (AQL) for lot-by-lot inspection (ISO 2859-1:1999 + Cor. 1:2001 + Amd.1:2011); Text in German and English More 
DIN ISO 3534-2 2013-12 Statistics - Vocabulary and symbols - Part 2: Applied statistics (ISO 3534-2:2006); Text in German and English More 
ISO 13485 2016-03 Medical devices - Quality management systems - Requirements for regulatory purposes More