I.S. EN 285:2015+A1:2021

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
11.1 Protective measures
11.2 Risk control, 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
Figure 12 — Apparatus for sampling steam condensate
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 General
Safety and Performance Requirements of Regulation (EU) 2017/745 aimed to be
covered
Bibliography

This document 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.