DIN EN ISO 11138-1:2015-10 (Draft)

Superseded

STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL INDICATORS - PART 1: GENERAL REQUIREMENTS (ISO 11138-1:2017)

Available format(s)

Hardcopy , PDF

Superseded date

07-03-2021

Language(s)

German

Published date

01-01-2015

Publisher

German Institute for Standardisation (Deutsches Institut für Normung)

DevelopmentNote	Supersedes DIN EN 866-1 and DIN EN 866-1 E. (09/2006)
DocumentType	Draft
Pages	98
PublisherName	German Institute for Standardisation (Deutsches Institut für Normung)
Status	Superseded
Supersedes	DIN EN 866-1:1997-05

Standards	Relationship
ISO 11138-1:2017	Identical
NF EN ISO 11138-1 : 2017	Identical
NBN EN ISO 11138-1 : 2006	Identical
NEN EN ISO 11138-1 : 2017	Identical
NS EN ISO 11138-1 : 2017	Identical
I.S. EN ISO 11138-1:2017	Identical
SN EN ISO 11138-1:2017	Identical
UNI EN ISO 11138-1 : 2006	Identical
UNE-EN ISO 11138-1:2007	Identical
BS EN ISO 11138-1:2017	Identical
EN ISO 11138-1:2017	Identical
UNE-EN ISO 11138-1:2017	Identical

DIN EN ISO 11135:2014-10	STERILIZATION OF HEALTH CARE PRODUCTS - ETHYLENE OXIDE - REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES (ISO 11135:2014)
DIN EN ISO 15883-4:2009-09	WASHER-DISINFECTORS - PART 4: REQUIREMENTS AND TESTS FOR WASHER-DISINFECTORS EMPLOYING CHEMICAL DISINFECTION FOR THERMOLABILE ENDOSCOPES
DIN EN ISO 15883-4:2016-07 (Draft)	WASHER-DISINFECTORS - PART 4: REQUIREMENTS AND TESTS FOR WASHER-DISINFECTORS EMPLOYING CHEMICAL DISINFECTION FOR THERMOLABILE ENDOSCOPES
VDI 6300 Blatt 1:2016-05	Genetic engineering operations in genetic engineering facilities - Guidance on safe operation of genetic engineering facilities
DIN EN ISO 20857 E : 2013	STERILIZATION OF HEALTH CARE PRODUCTS - DRY HEAT - REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES (ISO 20857:2010)
DIN EN ISO 20857:2013-08	Sterilization of health care products - Dry heat - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 20857:2010)
DIN EN ISO 14160:2011-10	Sterilization of health care products - Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives - Requirements for characterization, development, validation and routine control of a sterilization process for medical devices (ISO 14160:2011)
DIN EN ISO 14534:2015-08	Ophthalmic optics - Contact lenses and contact lens care products - Fundamental requirements (ISO 14534:2011)
DIN HDBK 265 : 2ED 2012	STERILISATION VON MEDIZINPRODUKTEN - INDIKATOREN UND VERPACKUNGEN FUER IN DER ENDVERPACKUNG ZU STERILISIERENDE MEDIZINPRODUKTE
DIN EN ISO 11138-5:2015-10 (Draft)	STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL INDICATORS - PART 5: BIOLOGICAL INDICATORS FOR LOW-TEMPERATURE STEAM AND FORMALDEHYDE STERILIZATION PROCESSES (ISO 11138-5:2017)
DIN EN ISO 15883-1:2014-10	WASHER-DISINFECTORS - PART 1: GENERAL REQUIREMENTS, TERMS AND DEFINITIONS AND TESTS (ISO 15883-1:2006 + AMD 1:2014)
DIN EN ISO 11138-3:2015-10 (Draft)	STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL INDICATORS - PART 3: BIOLOGICAL INDICATORS FOR MOIST HEAT STERILIZATION PROCESSES (ISO 11138-3:2017)
DIN EN ISO 11138-2:2015-10 (Draft)	STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL INDICATORS - PART 2: BIOLOGICAL INDICATORS FOR ETHYLENE OXIDE STERILIZATION PROCESSES (ISO 11138-2:2017)
DIN EN ISO 11138-4:2015-10 (Draft)	STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL INDICATORS - PART 4: BIOLOGICAL INDICATORS FOR DRY HEAT STERILIZATION PROCESSES (ISO 11138-4:2017)
DIN EN ISO 14937:2010-03	Sterilization of health care products - General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices (ISO 14937:2009)

DIN EN ISO 11135:2014-10	STERILIZATION OF HEALTH CARE PRODUCTS - ETHYLENE OXIDE - REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES (ISO 11135:2014)
DIN ISO 8601:2006-09	DATA ELEMENTS AND INTERCHANGE FORMATS - INFORMATION INTERCHANGE - REPRESENTATION OF DATES AND TIMES
DIN EN ISO 15223-1:2015-08 (Draft)	MEDICAL DEVICES - SYMBOLS TO BE USED WITH MEDICAL DEVICE LABELS, LABELLING AND INFORMATION TO BE SUPPLIED - PART 1: GENERAL REQUIREMENTS (ISO 15223-1:2016, CORRECTED VERSION 2017-03)
DIN EN ISO 13485:2016-08	Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)
ISO 11135:2014	Sterilization of health-care products Ethylene oxide Requirements for the development, validation and routine control of a sterilization process for medical devices
ISO 11737-1:2006	Sterilization of medical devices Microbiological methods Part 1: Determination of a population of microorganisms on products
ISO 13485:2016	Medical devices Quality management systems Requirements for regulatory purposes
ISO 14937:2009	Sterilization of health care products General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices
DIN EN ISO 14161:2010-03	STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL INDICATORS - GUIDANCE FOR THE SELECTION, USE AND INTERPRETATION OF RESULTS
ISO 11140-1:2014	Sterilization of health care products Chemical indicators Part 1: General requirements
DIN EN ISO 17665-1:2006-11	Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 17665-1:2006)
ISO 18472:2006	Sterilization of health care products Biological and chemical indicators Test equipment
ISO 8601:2004	Data elements and interchange formats Information interchange Representation of dates and times
ISO/TS 11139:2006	Sterilization of health care products Vocabulary
DIN EN ISO 18472:2006-10	STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL AND CHEMICAL INDICATORS - TEST EQUIPMENT
DIN EN ISO 11737-1:2009-09	STERILIZATION OF MEDICAL DEVICES - MICROBIOLOGICAL METHODS - PART 1: DETERMINATION OF A POPULATION OF MICROORGANISMS ON PRODUCTS
ISO 14161:2009	Sterilization of health care products Biological indicators Guidance for the selection, use and interpretation of results
ISO 15223-1:2016	Medical devices Symbols to be used with medical device labels, labelling and information to be supplied Part 1: General requirements
ISO 17665-1:2006	Sterilization of health care products — Moist heat — Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices
DIN EN ISO 11140-1:2015-03	Sterilization of health care products - Chemical indicators - Part 1: General requirements (ISO 11140-1:2014)