BS EN 1422:1997+A1:2009
Sterilizers for medical purposes - Ethylene oxide sterilizers - Requirements and test methods

Standard No.

BS EN 1422:1997+A1:2009

Release Date

1998

Published By

British Standards Institution (BSI)

Status

Be replaced 2014-05

Replace By

BS EN 1422:2014

Latest

BS EN 1422:2014

Replace

94/505596 DC-1994 BS EN 1422:1998 BS 3970-1:1990

Scope

1.1 This European standard 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 this standard 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 This standard 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. 1.3 This standard does not specify those tests which are necessary to determine the probability of a 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 This standard 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. 1.6 This 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. This standard is not intended as a checklist for suitability of an existing ethylene oxide sterilizer when assessing compliance with EN 550.

BS EN 1422:1997+A1:2009 Referenced Document

• EN 50081-1 Electromagnetic Compatibility - Generic Emission Standard Part 1: Residential@ Commercial and Light Industry
• EN 50081-2 Electromagnetic Compatibility - Generic Emission Standard Part 2: Industrial Environment
• EN 50082-1 Electromagnetic Compatibility - Generic Immunity Standard Part 1: Residential@ Commercial and Light Industry
• EN 50082-2 Electromagnetic Compatibility Generic Immunity Standard Part 2: Industrial Environment
• EN 60584-2 Thermocouples Part 2: Tolerances (Remains Current)
• EN 60651:1994 Sound Level Meters (Incorporates Amendments A1: 1994 and A2: 2001)
• EN 60804:1994 Integrating-Averaging Sound Level Meters (Incorporates Amendment A2: 1994)
• EN 866-1 Biological Systems for Testing Sterilizers and Sterilization Processes - Part 1: General Requirements
• EN 866-2 Biological Systems for Testing Sterilizers and Sterilization Processes - Part 2: Particular Systems for Use in Ethylene Oxide Sterilizers
• EN 868-1 Packaging Materials and Systems for Medical Devices Which Are to Be Sterilized - Part 1: General Requirements and Test Methods
• EN ISO 3746:1995 Acoustics - Determination of Sound Power Levels of Noise Sources Using Sound Pressure - Survey Method Using an Enveloping Measurement Surface over a Reflecting Plane (ISO 3746 : 1995)
• ISO 10012-1 Quality assurance requirements for measuring equipment; part 1: metrological confirmation system for measuring equipment
• ISO 228-1 Pipe threads where pressure-tight joints are not made on the threads - Part 1: Dimensions, tolerances and designation*， 2000-09-01 Update
• ISO 6780 Flat pallets for intercontinental materials handling — Principal dimensions and tolerances*， 2003-12-01 Update
• prEN 868-4 Packaging materials for sterilization of wrapped goods; part 4: paper bags; requirements and tests
• prEN 868-5 Packaging materials for sterilization of wrapped goods; part 5: heat sealable pouches and reel material of paper and plastic film construction; requirements and tests

BS EN 1422:1997+A1:2009 history

• 2014 BS EN 1422:2014 Sterilizers for medical purposes. Ethylene oxide sterilizers. Requirements and test methods
• 1998 BS EN 1422:1997+A1:2009 Sterilizers for medical purposes - Ethylene oxide sterilizers - Requirements and test methods
• 1990 BS 3970-1:1990 Sterilizing and disinfecting equipment for medical products - Specification for general requirements