EN 285:2015

European foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Mechanical components
5 Piping system and components
6 Measuring system, indicating and recording devices
   for temperature, pressure, time and status indicators
7 Control systems
8 Performance requirements
9 Sound power and vibration
10 Rate of pressure change
11 Safety, risk control and usability
12 Packaging and marking
13 Service and working environment
14 Testing
15 Hollow load test
16 Thermometric tests
17 Bowie and Dick test
18 Air leakage test
19 Air detector tests
20 Load dryness test
21 Steam quality test
22 Rate of pressure change
23 Test apparatus, equipment and material
24 Documentation to be supplied with the sterilizer
25 Information to be supplied with the sterilizer
Annex A (informative) - Environmental aspects
Annex B (informative) - Suggested maximum values of
        contaminants in feed water
Annex C (informative) - Temperature and time tolerances
        during the small load thermometric test
Annex D (informative) - Guidance for installation and
        operational qualification tests which can be included
        in the instructions for use supplied with a sterilizer
Annex E (informative) - Criteria for identifying sterilizers as
        the same type
Annex F (normative) - Protective measures
Annex ZA (informative) - Relationship between this
         European Standard and the Essential
         Requirements of EU Directive 93/42/EEC on
         medical devices
Bibliography

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 1Attention is drawn to the standards for quality management systems e.g. EN ISO 13485.NOTE 2Environmental aspects are addressed in Annex A.