EN 285:2006/prA1
(Amendment)Sterilization - Steam sterilizers - Large sterilizers
Sterilization - Steam sterilizers - Large sterilizers
This amendment specifies a test method to demonstrate that at the levels at which the controls are set, air dilution from within the test piece is sufficient to permit even steam penetration into it.
Sterilisation - Dampf-Sterilisatoren - Groß-Sterilisatoren
Stérilisation - Stérilisateurs à la vapeur d'eau - Grands stérilisateurs
Sterilizacija – Parni sterilizatorji – Veliki sterilizatorji
General Information
Relations
Overview
EN 285:2006/prA1 is an important amendment to the European Standard EN 285:2006, which focuses on sterilization using large steam sterilizers. Developed by the European Committee for Standardization (CEN) Technical Committee CEN/TC 102, this amendment introduces a new hollow load test method. This test verifies that air dilution within the sterilizer's test piece is sufficiently effective to ensure uniform steam penetration-a crucial factor in the sterilization process for medical devices that include instruments with long lumens or hollow channels.
The amendment aims to enhance the overall validation and performance testing of large steam sterilizers, ensuring better sterilization safety and process reliability in healthcare environments.
Key Topics
Hollow Load Test
This key addition to EN 285:2006/prA1 provides a practical, repeatable test procedure to demonstrate that air dilution during the steam sterilization cycle is adequate inside hollow or lumened devices. Proper air removal and steam penetration are necessary to achieve complete sterilization and avoid areas where pathogens might survive.Indicator Systems and Process Challenge Devices
The amendment references EN 867-5, defining specifications for non-biological indicator systems and process challenge devices suitable for this type of performance testing. These are used in conjunction with the hollow load test to visually or chemically confirm sterilization efficacy.Test Procedure
The amendment details the preparation of the hollow load challenge device, including temperature and humidity conditioning, cycle selection based on sterilizer settings, placement of the test device in the chamber, and post-sterilization evaluation of the indicator system.Improved Air Dilution Assurance
Current textile-based tests may not sufficiently represent the challenges in sterilizing hollow lumened instruments. The hollow load test complements existing tests, providing a more rigorous assurance of air removal and steam penetration in complex device geometries.Standards Compliance and Modification
Upon approval, this amendment modifies essential clauses in EN 285:2006 related to testing requirements, apparatus, and acceptance criteria, while aligning related normative references and deleting outdated test methods.
Applications
Medical Device Sterilization
Hospitals and healthcare facilities using large steam sterilizers can implement the hollow load test to verify that sterilization cycles adequately process complex, hollow instruments like endoscopes, surgical tubing, and other lumened devices.Sterilizer Manufacturing Quality Control
Manufacturers of large steam sterilizers can incorporate the hollow load test into their type testing and validation processes to ensure compliance with enhanced European standards and improve product reliability.Regulatory Compliance
Compliance with EN 285:2006/prA1 supports meeting European regulatory requirements for sterilization performance, crucial for medical device processing and patient safety.Sterilization Process Validation
Sterilization service providers can use this amendment’s methods as part of their routine operational qualification tests to confirm that sterilizers consistently maintain sterilization efficacy, particularly for challenging hollow loads.
Related Standards
EN 285:2006
The main European standard detailing requirements for steam sterilization and testing of large sterilizers.EN 867-5
Specifies requirements for non-biological indicator systems and process challenge devices used in performance testing, particularly complementary to the hollow load test.ISO 17665-1 (not explicitly cited but relevant)
Provides general requirements for steam sterilization procedures, including validation and routine control, which can be used alongside EN 285 amendments.
By incorporating the EN 285:2006/prA1 amendment, healthcare providers and sterilizer manufacturers strengthen their sterilization quality assurance programs, especially for hollow medical devices. The standardized hollow load test introduced ensures thorough air dilution and steam penetration, crucial for patient safety and infection control.
Standards Content (Sample)
SLOVENSKI SIST EN 285:2006/oprA1:2006
PREDSTANDARD
september 2006
Sterilizacija – Parni sterilizatorji – Veliki sterilizatorji
Sterilization - Steam sterilizers - Large sterilizers
ICS 11.080.10 Referenčna številka
© Standard je založil in izdal Slovenski inštitut za standardizacijo. Razmnoževanje ali kopiranje celote ali delov tega dokumenta ni dovoljeno
EUROPEAN STANDARD
DRAFT
EN 285:2006
NORME EUROPÉENNE
EUROPÄISCHE NORM
prA1
July 2006
ICS
English Version
Sterilization - Steam sterilizers - Large sterilizers
Stérilisation - Stérilisateurs à la vapeur d'eau - Grands Sterilisation - Dampf-Sterilisatoren - Groß-Sterilisatoren
stérilisateurs
This draft amendment is submitted to CEN members for enquiry. It has been drawn up by the Technical Committee CEN/TC 102.
This draft amendment A1, if approved, will modify the European Standard EN 285:2006. If this draft becomes an amendment, CEN
members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for inclusion of this amendment
into the relevant national standard without any alteration.
This draft amendment was established by CEN in three official versions (English, French, German). A version in any other language made
by translation under the responsibility of a CEN member into its own language and notified to the Management Centre has the same status
as the official versions.
CEN members are the national standards bodies of Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia, Finland, France,
Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania,
Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.
Recipients of this draft are invited to submit, with their comments, notification of any relevant patent rights of which they are aware and to
provide supporting documentation.
: This document is not a European Standard. It is distributed for review and comments. It is subject to change without notice and
Warning
shall not be referred to as a European Standard.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: rue de Stassart, 36 B-1050 Brussels
© 2006 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN 285:2006/prA1:2006: E
worldwide for CEN national Members.
Contents Page
Foreword.3
Revised text.3
2 Clause.3
8.3.5 Hollow load test .3
15 Hollow load test .4
15.1 General.4
15.2 Apparatus.4
15.3 Procedure.4
Foreword
This document (EN 285:2006/prA1:2006) has been prepared by Technical Committee CEN/TC 102
“Sterilizers for medical purposes”, the secretariat of which is held by DIN.
This document is currently submitted to the CEN Enquiry.
Revised text
2 Clause
Add
EN 867-5, Non-biological systems for use in sterilizers – Part 5: Specification for indicator systems and
process challenge devices for use in performance testing for small sterilizers type B and type S
7.1.13
Delete at the end of the first sentence "(e.g. the sterilization of instruments, textiles, rubber)"
8.1.3
replace the text of "NOTE 2" by the following
...
Frequently Asked Questions
EN 285:2006/prA1 is a draft published by the European Committee for Standardization (CEN). Its full title is "Sterilization - Steam sterilizers - Large sterilizers". This standard covers: This amendment specifies a test method to demonstrate that at the levels at which the controls are set, air dilution from within the test piece is sufficient to permit even steam penetration into it.
This amendment specifies a test method to demonstrate that at the levels at which the controls are set, air dilution from within the test piece is sufficient to permit even steam penetration into it.
EN 285:2006/prA1 is classified under the following ICS (International Classification for Standards) categories: 11.080.10 - Sterilizing equipment. The ICS classification helps identify the subject area and facilitates finding related standards.
EN 285:2006/prA1 has the following relationships with other standards: It is inter standard links to EN 285:2006+A1:2008, EN 285:2006. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
EN 285:2006/prA1 is associated with the following European legislation: EU Directives/Regulations: 93/42/EEC. When a standard is cited in the Official Journal of the European Union, products manufactured in conformity with it benefit from a presumption of conformity with the essential requirements of the corresponding EU directive or regulation.
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