EN 285:2015/FprA1
(Amendment)Sterilization - Steam sterilizers - Large sterilizers
Sterilization - Steam sterilizers - Large sterilizers
This European Standard specifies requirements and the relevant tests for large steam sterilizers primarily used in health care for the sterilization of medical devices and their accessories contained in one or more sterilization modules. The test loads described in this European Standard are selected to represent the majority of loads (i.e. wrapped goods consisting of metal, rubber and porous materials) for the evaluation of general purpose steam sterilizers for medical devices. However, specific loads (e.g. heavy metal objects or long and/or narrow lumen) will require the use of other test loads.
This European Standard applies to steam sterilizers designed to accommodate at least one sterilization module or having a chamber volume of at least 60 l.
Large steam sterilizers can also be used during the commercial production of medical devices.
This European Standard does not specify requirements for equipment intended to use, contain or be exposed to flammable substances or substances which could cause combustion. This European Standard does not specify requirements for equipment intended to process biological waste or human tissues.
This European Standard does not describe a quality management system for the control of all stages of the manufacture of the sterilizer.
NOTE 1 Attention is drawn to the standards for quality management systems e.g. EN ISO 13485.
NOTE 2 Environmental aspects are addressed in Annex A.
Sterilisation - Dampf-Sterilisatoren - Groß-Sterilisatoren
No Scope available
Stérilisation - Stérilisateurs à la vapeur d'eau - Grands stérilisateurs
No scope available
Sterilizacija - Parni sterilizatorji - Veliki sterilizatorji
General Information
- Status
- Not Published
- Publication Date
- 24-Oct-2021
- Withdrawal Date
- 23-Jan-2022
- Technical Committee
- CEN/TC 102 - Sterilizers for medical purposes
- Drafting Committee
- CEN/TC 102/WG 5 - Small sterilizers
- Current Stage
- 5060 - Closure of Vote - Formal Approval
- Start Date
- 22-Apr-2021
- Completion Date
- 22-Apr-2021
Relations
- Effective Date
- 19-Jan-2023
- Effective Date
- 02-May-2018
Overview - EN 285:2015/FprA1 (Large Steam Sterilizers)
EN 285:2015 (draft amendment prA1/2018) is a European Standard from CEN that specifies requirements and test methods for large steam sterilizers used primarily in health care for sterilizing medical devices and accessories contained in one or more sterilization modules. It applies to sterilizers designed to accommodate at least one module or having a chamber volume of at least 60 L. The standard covers general-purpose steam sterilization loads (wrapped metal, rubber and porous materials) and notes that specific or atypical loads (e.g., heavy metal items or long/narrow lumens) require other test loads.
Key topics and technical requirements
- Scope & exclusions
- Applies to large steam sterilizers for medical devices and also to commercial production uses.
- Does not cover equipment for flammable materials, processing biological waste or human tissues, nor does it itself define a quality management system.
- Test loads and performance evaluation
- Test loads represent common wrapped goods (metal, rubber, porous materials); special loads need dedicated evaluation.
- Pressure and measurement systems
- Amendment introduces clarifications for measuring systems and pressure measuring chains (new sub-clause 6.4.4.2 for jacket and steam supply):
- Indication in kPa or bar
- Accuracy ±1.6% (over 0–400 kPa)
- Graduations not greater than 20 kPa
- Means for in situ adjustment without dismantling
- Amendment introduces clarifications for measuring systems and pressure measuring chains (new sub-clause 6.4.4.2 for jacket and steam supply):
- Steam requirements
- Notes discussion points on steam penetration and the definition of saturated steam shared with ISO working groups (ISO/TC 198/WG 3).
- Ancillary content
- Environmental aspects are addressed (Annex A).
- Informative Annex ZA ties the standard to relevant EU directives.
Practical applications - who uses EN 285
- Manufacturers of large steam sterilizers (design, testing, conformity)
- Biomedical/sterile processing engineers validating sterilization cycles and equipment
- Hospital sterilization departments (CSSDs) evaluating or procuring large sterilizers
- Test laboratories and certification bodies performing type testing and compliance checks
- Regulatory and quality professionals ensuring equipment meets EU requirements (see EN ISO 13485 for QMS)
Related standards
- EN ISO 17665 series - sterilization of health care products (process validation and control)
- EN ISO 13485 - quality management systems for medical devices
- ISO/TC 198 work on steam sterilization (steam penetration and saturated steam definitions)
Keywords: EN 285:2015/FprA1, steam sterilizers, large sterilizers, medical device sterilization, pressure measuring chains, saturated steam, sterilization validation, CEN.
Frequently Asked Questions
EN 285:2015/FprA1 is a draft published by the European Committee for Standardization (CEN). Its full title is "Sterilization - Steam sterilizers - Large sterilizers". This standard covers: This European Standard specifies requirements and the relevant tests for large steam sterilizers primarily used in health care for the sterilization of medical devices and their accessories contained in one or more sterilization modules. The test loads described in this European Standard are selected to represent the majority of loads (i.e. wrapped goods consisting of metal, rubber and porous materials) for the evaluation of general purpose steam sterilizers for medical devices. However, specific loads (e.g. heavy metal objects or long and/or narrow lumen) will require the use of other test loads. This European Standard applies to steam sterilizers designed to accommodate at least one sterilization module or having a chamber volume of at least 60 l. Large steam sterilizers can also be used during the commercial production of medical devices. This European Standard does not specify requirements for equipment intended to use, contain or be exposed to flammable substances or substances which could cause combustion. This European Standard does not specify requirements for equipment intended to process biological waste or human tissues. This European Standard does not describe a quality management system for the control of all stages of the manufacture of the sterilizer. NOTE 1 Attention is drawn to the standards for quality management systems e.g. EN ISO 13485. NOTE 2 Environmental aspects are addressed in Annex A.
This European Standard specifies requirements and the relevant tests for large steam sterilizers primarily used in health care for the sterilization of medical devices and their accessories contained in one or more sterilization modules. The test loads described in this European Standard are selected to represent the majority of loads (i.e. wrapped goods consisting of metal, rubber and porous materials) for the evaluation of general purpose steam sterilizers for medical devices. However, specific loads (e.g. heavy metal objects or long and/or narrow lumen) will require the use of other test loads. This European Standard applies to steam sterilizers designed to accommodate at least one sterilization module or having a chamber volume of at least 60 l. Large steam sterilizers can also be used during the commercial production of medical devices. This European Standard does not specify requirements for equipment intended to use, contain or be exposed to flammable substances or substances which could cause combustion. This European Standard does not specify requirements for equipment intended to process biological waste or human tissues. This European Standard does not describe a quality management system for the control of all stages of the manufacture of the sterilizer. NOTE 1 Attention is drawn to the standards for quality management systems e.g. EN ISO 13485. NOTE 2 Environmental aspects are addressed in Annex A.
EN 285:2015/FprA1 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 285:2015/FprA1 has the following relationships with other standards: It is inter standard links to EN 285:2015+A1:2021, EN 285:2015. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
EN 285:2015/FprA1 is associated with the following European legislation: EU Directives/Regulations: 2017/745, 93/42/EEC; Standardization Mandates: M/023, M/565, M/575, M/575 AMD 1, M/575 AMD 2. 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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Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN 285:2016/oprA1:2018
01-december-2018
Sterilizacija - Parni sterilizatorji - Veliki sterilizatorji
Sterilization - Steam sterilizers - Large sterilizers
Sterilisation - Dampf-Sterilisatoren - Groß-Sterilisatoren
Stérilisation - Stérilisateurs à la vapeur d'eau - Grands stérilisateurs
Ta slovenski standard je istoveten z: EN 285:2015/prA1:2018
ICS:
11.080.10 Sterilizacijska oprema Sterilizing equipment
SIST EN 285:2016/oprA1:2018 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
SIST EN 285:2016/oprA1:2018
SIST EN 285:2016/oprA1:2018
DRAFT
EUROPEAN STANDARD
EN 285:2015
NORME EUROPÉENNE
EUROPÄISCHE NORM
prA1
September 2018
ICS 11.080.10
English Version
Sterilization - Steam sterilizers - Large sterilizers
Stérilisation - Stérilisateurs à la vapeur d'eau - Grands Sterilisation - Dampf-Sterilisatoren - Groß-
stérilisateurs Sterilisatoren
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 285:2015. 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 CEN-CENELEC
Management Centre has the same status as the official versions.
CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,
Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Turkey 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.
Warning : This document is not a European Standard. It is distributed for review and comments. It is subject to change without
notice and shall not be referred to as a European Standard.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2018 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN 285:2015/prA1:2018:2018 E
worldwide for CEN national Members.
SIST EN 285:2016/oprA1:2018
EN 285:2015/prA1:2018 (E)
Contents Page
European foreword . 3
1 Modification to Clause 3, Terms and definitions . 4
2 Modification to 6.2, Measuring system . 4
3 Modification to 6.4.4, Pressure measuring chains for cont
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