BS EN ISO 11135-1:2007 - Sterilization of health care products. Ethylene oxide. Requirements for development, validation and routine control of a sterilization process for medical devices – BSI British Standards

BS EN ISO 11135-1:2007

Sterilization of health care products. Ethylene oxide. Requirements for development, validation and routine control of a sterilization process for medical devices

Status : Superseded, Withdrawn   Published : June 2007 Replaced By :

WITHDRAWN TITLE
*To ask about withdrawn titles contact the
BSI Customer Services
cservices@bsigroup.com, +44 345 086 9001


BS EN ISO 11135-1:2007 specifies requirements for the development, validation and routine control of an ethylene oxide sterilization process for medical devices.

A sterile medical device is one that is free of viable microorganisms. International Standards that specify requirements for validation and routine control of sterilization processes, require, when it is necessary to supply a sterile medical device, that adventitious microbiological contamination of a medical device prior to sterilization be minimized. Even so, medical devices produced under standard manufacturing conditions in accordance with the requirements for quality management systems may, prior to sterilization, have microorganisms on them, albeit in low numbers. Such medical devices are non-sterile. The purpose of sterilization is to inactivate the microbiological contaminants and thereby transform the non-sterile medical devices into sterile ones.

The kinetics of inactivation of a pure culture of microorganisms by physical and/or chemical agents used to sterilize medical devices can generally best be described by an exponential relationship between the numbers of microorganisms surviving and the extent of treatment with the ethylene oxide; inevitably this means that there is always a finite probability that a microorganism may survive regardless of the extent of treatment applied. For a given treatment, the probability of survival is determined by the number and resistance of microorganisms and by the environment in which the organisms exist during treatment. It follows that the sterility of any one medical device in a population subjected to sterilization processing cannot be guaranteed and the sterility of a processed population is defined in terms of the probability of there being a viable microorganism present on a medical device.

BS EN ISO 11135-1:2007 describes requirements that, if met, will provide an ethylene oxide sterilization process intended to sterilize medical devices, which has appropriate microbicidal activity. Furthermore, compliance with the requirements ensures that this activity is both reliable and reproducible so that it can be predicted, with reasonable confidence, that there is a low level of probability of there being a viable microorganism present on product after sterilization. Specification of this probability is a matter for regulatory authorities and may vary from country to country.

Generic requirements of the quality management systems for design and development, production, installation and servicing are given in ISO 9001 and particular requirements for quality management systems for medical device production are given in ISO 13485. The standards for quality management systems recognise that, for certain processes used in manufacturing or reprocessing, the effectiveness of the process cannot be fully verified by subsequent inspection and testing of the product. Sterilization is an example of such a process. For this reason, sterilization processes are validated for use, the performance of the sterilization process
monitored routinely and the equipment maintained.

Exposure to a properly validated, accurately controlled sterilization process is not the only factor associated with the provision of reliable assurance that the product is sterile and, in this regard, suitable for its intended use. Attention is therefore given to a number of considerations including:

a) the microbiological status of incoming raw materials and/or components;
b) the validation and routine control of any cleaning and disinfection procedures used on the product;
c) the control of the environment in which the product is manufactured or reprocessed, assembled and packaged;
d) the control of equipment and processes;
e) the control of personnel and their hygiene;
f) the manner and materials in which the product is packaged;
g) the conditions under which product is stored.




Standard NumberBS EN ISO 11135-1:2007
TitleSterilization of health care products. Ethylene oxide. Requirements for development, validation and routine control of a sterilization process for medical devices
StatusSuperseded, Withdrawn
Publication Date29 June 2007
Withdrawn Date31 July 2014
Normative References(Required to achieve compliance to this standard)BS EN ISO 11737-2:2019, ISO 11737-2:2019, ISO 14161, ISO 11737-1:2018, ISO 10993-7, ISO 10993-1, ISO 11140-1, ISO 11138-1:2006, ISO 13485:2003, ISO 14937:2000, ISO 10012, ISO 11138-2:2006
Informative References(Provided for Information)ANSI/AAMI ST67, ISO 9001, IEC 61010-2-040, IEC 61010-1, ISO 11607-2, EN 556-1, ISO 9000:2005, AAMI TIR16, VIM:1993, ISO 14971, ISO 14001, ISO/IEC 90003, ISO 14040, ISO 22442-1, ISO 11607-1, 93/42/EEC, ISO 22442-2, ISO/TS 11139:2006, ISO 22442-3, ISO 9001:2000, ISO 17664:2017
ReplacesBS EN 550:1994
International RelationshipsEN ISO 11135-1:2007,ISO 11135-1:2007
Draft Superseded By04/30048118 DC05/30141532 DC
DescriptorsSterilizers, Performance, Management, Personnel, Verification, Quality control, Maintenance, Acceptance (approval), Sterilization (hygiene), Medical equipment, Sterile equipment, Medical instruments, Microbiological analysis, Ethylene oxide, Performance testing, Hygiene, Instructions for use
ICS11.080.01
Title in FrenchStérilisation des produits de santé. Oxyde d'éthylène. Exigences de développement, de validation et de contrôle de routine d'un processus de stérilisation pour des dispositifs médicaux
Title in GermanSterilisation von Produkten für die Gesundheitsfürsorge. Ethylenoxid. Anforderungen an die Entwicklung, Validierung und Lenkung der Anwendung eines Sterilisationsverfahrens für Medizinprodukte
CommitteeCH/198
ISBN978 0 580 50880 6
PublisherBSI
FormatA4
DeliveryNo
Pages54
File Size791 KB
Price£254.00


WITHDRAWN TITLE
*To ask about withdrawn titles contact the
BSI Customer Services
cservices@bsigroup.com, +44 345 086 9001
 Your basket
Your basket is empty

Multi-user access to over 3,500 medical device standards, regulations, expert commentaries and other documents


Collaborate, Innovate, Accelerate.


BSOL

The faster, easier way to work with standards


Tracked Changes

Understand the changes made to a standard with our new Tracked Changes version


Customers who bought this product also bought

  • BS EN 556-1:2001
    Sterilization of medical devices. Requirements for medical devices to be designated "STERILE" Requirements for terminally sterilized medical devices
  • BS EN ISO 17665-1:2006
    Sterilization of health care products. Moist heat Requirements for the development, validation and routine control of a sterilization process for medical devices
  • BS EN ISO 10993-7:2008
    Biological evaluation of medical devices Ethylene oxide sterilization residuals
  • BS EN ISO 10993-18:2009
    Biological evaluation of medical devices Chemical characterization of materials