BS EN 1422:1997+A1:2009

BS EN 1422:1997+A1:2009 specifies the minimum performance requirements and test methods of two types of sterilizers employing ethylene oxide gas as the sterilant, either as a pure gas or in admixture with other gases (whether supplied ready mixed or mixed at the point of use) in a temporarily sealed chamber.

These sterilizers are intended to be used for medical, dental, pharmaceutical, veterinary and industrial or related purposes. The two types of sterilizers have been designated Type A and Type B respectively using the following criteria:

- Type A sterilizers are capable of being programmed by the user;

- Type B sterilizers are of limited size and provided with one or more pre-set operating cycles which cannot be varied by the user.

The clauses of BS EN 1422:1997+A1:2009 apply to both types of sterilizer unless it is specifically indicated within the clause that it applies only to one of the types in particular.

1.2 BS EN 1422:1997+A1:2009 includes minimum performance and construction requirements for sterilizers working above or below atmospheric pressure:

- To ensure that the process is capable of being used to sterilize medical products;

- For the equipment and controls necessary to permit validation and monitoring of the sterilization process. processed product being sterile, nor the routine quality control tests required prior to release of sterile product. These topics are addressed in EN 550.

1.4 BS EN 1422:1997+A1:2009 does not specify the procedures and equipment which can be used to improve the efficacy and/or efficiency of the process before or after the sterilization cycle.

1.5 Considerations of operator safety are addressed in EN 61010-1: A2 and IEC 1010-2-042.

BS EN 1422:1997+A1:2009This standard is applicable when:

a) specified in a contract for supply of an ethylene oxide sterilizer; or,

b) a sterilizer manufacturer declares compliance when intending to supply an ethylene oxide sterilizer.

BS EN 1422:1997+A1:2009 is not intended as a checklist for suitability of an existing ethylene oxide sterilizer when assessing compliance with EN 550.

Cross References:
EN 285
EN 550
EN 554
EN 556
prEN 866-8
prEN 868-2
prEN 868-3
prEN 868-6
prEN 868-7
EN 1174-1
EN 46001
EN ISO 10993-7
ISO 10993-7:1995
EN ISO 9001
ISO 9001:1994
84/404/EEC
93/42/EEC
2006/42/EC
EN 866-1
EN 866-2
EN 868-1
prEN 868-4
prEN 868-5
EN 50081-1
EN 50081-2
EN 50082-1
EN 50082-2
EN 60584-2
IEC 60584-2:1982
IEC 60584-2/AMD 1:1989
EN 60651:1994
IEC 60651:1979
IEC 60651/AMD 1:1993
EN 60751
EN 60751/A2
IEC 60751:1983
IEC 60751/AMD 2:1995
EN 60804:1994
IEC 60804:1985
IEC 60804/AMD 1:1989
EN 61010-1
EN 61010-1/A2
IEC 61010-1:1990
IEC 61010-1/AMD 1:1992
IEC 61010-1/AMD 2:1995
EN ISO 3746:1995
ISO 3746:1995
IEC 60073
IEC 61010-2-042
ISO 228-1
ISO 6780
ISO 10012-1


Partially replaces BS 3970-1:1990.

Incorporates the following:
AMD 14232 published 21 February 2003
AMD 14232 is a Corrigendum. Amendment, November 2009. Amends and replaces BS EN 1422:1998