Description of BS EN ISO 15883-1:2009+A1:2014 2014

2 Normative references (modified)

The normative references have been updated to reflect current editions of standards and standards that have replaced ones previously listed. Note in particular the inclusion of IEC 61010‑2‑040:2005, Safety requirements for electrical equipment for measurement, control and laboratory use — Part 2-040: Particular requirements for sterilizers and washer-disinfectors used to treat medical materials (see commentary on Clause 5).

3 Terms and definitions (modified)

A number of minor changes have been made to the definitions to harmonize these with other standards. These include the definitions of bioburden (3.4) and D value (3.14).

5 Mechanical and process requirements (modified)

In the 2006 version of the washer-disinfector (WD) standard under Clause 5 Mechanical and Process Requirements, the safety requirements specified compliance to an older standard, IEC 61010-2-045, Safety requirements for electrical equipment for measurement, control, and laboratory use — Part 2-045: Particular requirements for washer disinfectors used in medical, pharmaceutical, veterinary and laboratory fields. This standard has since been withdrawn and is now replaced by IEC 61010‑2‑040:2005. In general, the working groups of CEN TC102 (including WG8) have decided to defer to IEC 61010-1 (Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 1: General requirements) and IEC 61010-2-040 as the basic standards regarding safety issues. EN 60601-1:2006+A1:2013 was recently updated and published. At the time of this report, the IEC 61010-2-040 standard is currently under revision by IEC TC66 Safety of measuring, control and laboratory equipment, in liaison with CEN TC 102.

A further safety requirement included in this update is regarding electromagnetic compatibility (EMC) and specifically requires compliance with IEC 61326‑1:2006, Electrical equipment for measurement, control and laboratory use — EMC requirements —Part 1: General requirements. WDs that are designed to operate in areas with medical electrical equipment or in the vicinity of other sensitive equipment are now regarded as class B equipment as specified in IEC 61326‑1.

It is important to note that compliance with these referenced standards may not be assumed to meet all the safety aspects of WD design and specifically the EU Machinery Directive 2006/42/EC. Therefore, the standard amendments also require risk analysis and management to be considered for WD design, including associated software. The standard specifically requires risks to be managed in compliance with ISO 14971, Medical devices - Application of risk management to medical devices. This is a major change and specifically highlights the need to consider aspects such as ease of use, ergonomics and the knowledge, experience and training of those intending to operate the WD.

5.20 Microprocessor control systems (modified)

The design criteria for any associated microprocessor control systems now include an additional requirement for the associated software to be validated.

8.3 At delivery of the WD (modified)

There are two new requirements for information to be provided by the manufacturer to the purchaser of the WD. These are to provide:

• the issue date/revision number of the instructions for use, and

• the name/address of the manufacturer, or representative authorized to act on their behalf, in the country or the economic area (e.g. European Union) in which the WD is being sold.

Annex ZA (modified)

The informative Annex ZA on the relationship between the published European Standard and the essential requirements of the EU Directive 93/42/EEC on medical devices (Table ZA.1) and EU Directive 2006/42/EC on machinery (Table ZA.2) has been updated. This Annex can be useful in verifying the presumption of conformity to the Directives, but it is important to note that other requirements or even other EU Directives may be applicable to the specific WD.

Bibliography (modified)

The bibliography has been updated to include current editions of relevant standards and applicable references.

Reviewers This commentary was peer reviewed by Colin Hunt, Market Development Manager, 3M Healthcare, and Barend ter Haar, Managing Director, BES Rehab Ltd.

Disclaimer This commentary is commissioned text from expert authorities in their industry. It has been commissioned, edited and peer-reviewed before publication but remains the personal opinion of the individual experts who have provided it. It is not official British Standards guidance. Accordingly, BSI cannot accept liability for any direct or indirect loss or damage arising from a reliance on the commentary except to the extent that such liability may not be excluded by law.

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