BS EN 285:2015 Sterilization. Steam sterilizers. Large sterilizers

BS EN 285:2015

Sterilization. Steam sterilizers. Large sterilizers

Status : Confirmed, Current   Published : January 2016



What is this standard about?

It details the requirements and tests for large steam sterilizers. The standard was revised to reference the relationship with Medical Devices Directive 93/42/EEC.

Who is this standard for?

  • Testing laboratories that include sterilizers in their service
  • Medical device manufacturers and installers that include sterilizers in their service
  • Personnel responsible for the maintenance of sterilizers in hospitals and laboratories
  • Personnel responsible for sterilization assurance

Why should you use this standard? 

It specifies requirements and the relevant tests for large steam sterilizers, primarily used in healthcare for the sterilization of medical devices and their accessories. It applies to steam sterilizers designed to accommodate at least one sterilization module or having a chamber volume of at least 60 l.

The test loads described in this 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.

What’s changed since the last update?

BS EN 285 was fully revised. Some of the amendments are:

  • Modified scope to differentiate small and large sterilizers by chamber size and to exclude equipment intended to use, contain or be exposed to flammable substances or substances which could cause combustion, and equipment intended to process pathogenic substances or human tissues
  • Redraft of clause 6 on instrumentation, indicating and recording devices 
  • Redrafted requirements on sound power and vibration are completely 
  • Redrafted requirements on safety, risk control and usability (Clause 11) including normative Annex F and reference to EN ISO 14971
  • Revised and extended requirements on packaging and marking (Clause 12) 
  • Extended requirements on service and working environment (Clause 13) 
  • Redrafted requirements on test measurement equipment
  • Revised and extended clauses on documentation and information
  • Redrafted Annex A on environmental aspects 
  • New normative Annex F on protective measures 
  • Revised Annex ZA relationship with the essential requirements of the Directive 93/42/ECC on Medical Devices including Tables ZA.1 and ZA.2

Standard NumberBS EN 285:2015
TitleSterilization. Steam sterilizers. Large sterilizers
StatusConfirmed, Current
Publication Date31 January 2016
Confirm Date10 June 2021
Normative References(Required to achieve compliance to this standard)EN 764-7:2002, EN 13445-5:2014, EN ISO 13408-2:2011, EN 60204-1:2006, EN ISO 3746:2010, EN 60584-1:2013, EN 61326-1:2013, ISO 12100:2010, EN 60751:2008, IEC 61010-1:2010, EN ISO 12100:2010, ISO 3746:2010, IEC 61010-2-040:2005, IEC 60770-1:2011, EN 61010-2-040:2005, ISO 13408-2:2003, EN 22768-1:1993, IEC 60204-1:2005, IEC 60584-1:2013, EN ISO 11140-3:2009, IEC 61326-1:2012, EN 61010-1:2010, EN 60770-1:2011, EN ISO 228-1:2003, ISO 11140-3:2007, IEC 60751:2008, EN 13445-1:2014, EN 13445-2:2014, EN 13445-4:2014, EN 867-5:2001, ISO 2768-1:1989, EN 1041:2008+A1:2013, ISO 228-1:2000, EN 13445-8:2014, EN 13445-3:2014, EN 14222:2003
Informative References(Provided for Information)EN 61508-1, 2006/42/EC, ISO/TS 17665-2:2009, EN ISO 17665-1:2006, ISO 11607-1, EN ISO 11140-4:2007, ISO 8573-1:2010, EN ISO 15883-1:2009, ISO 13485:2003, EN ISO 14971:2012, EN ISO 14937, IEC 61140, 93/42/EEC, ISO 15223-1:2012, IEC 61508-1, ISO 14050:2009, ISO 9000:2005, EN 13445, EN ISO 4017, EN 1837, EN ISO 11140-1:2009, EN 10088-3, EN ISO/IEC 17025:2005, EN ISO 14050:2010, EN ISO 14738:2008, EN 62366, EN ISO 11607-1, IEC 62061, EN 61508, IEC 61508, EN ISO 13485:2012, ISO 11140-1:2005, ISO/TS 11139:2006, EN 62061, ISO 15883-1:2006, EN 13060, EN ISO 9000:2005, ISO 14971:2007, ISO 3740:2000, EN ISO 15223-1:2012, ISO 14738:2002, EN 12953, 2014/68/EU, ISO/IEC 17025:2005, 2003/10/EC, EN 61032:1998, ISO 17665-1:2006, ISO 11140-4:2007, EN 61140, EN ISO 13732-1, ISO 13732-1, EN ISO 3740, CEN ISO/TS 17665-2:2009, IEC 62366, EN 868, EN 10088-2, ISO 14937, EN 62304, IEC 61032:1997, EN 547-1:1996+A1:2008, EN 547-3:1996+A1:2008, EN 547-2:1996+A1:2008, IEC 62304, EN 1717:2000, EN 764-1:2004, EN 556-1:2001, ISO 4017
ReplacesBS EN 285:2006+A2:2009
International RelationshipsEN 285:2015
Draft Superseded By13/30278676 DC
DescriptorsAir, Quality, Safety devices, Dimensional tolerances, Air permeability, Medical equipment, Marking, Pressure gauges, Type testing, Equipment safety, Control systems, Noise (environmental), Performance testing, Pressure testing, Leak tests, Steam, Steam sterilizers, Contaminants, Recording instruments (measurement), Design, Temperature-measuring instruments, Performance, Large, Instructions for use, Signal devices, Sterilization (hygiene), Safety measures, Sterilizers, Microbiological analysis
Title in FrenchStérilisation. Stérilisateurs à la vapeur d'eau. Grands stérilisateurs
Title in GermanSterilisation. Dampf-Sterilisatoren. Groß-Sterilisatoren
ISBN978 0 580 82033 5
File Size1.686 MB

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