IEC TR 61010-3-045-2003 PDF

Full title and description

St IEC TR 61010-3-045-2003 — Safety requirements for electrical equipment for measurement, control, and laboratory use — Part 3-045: Conformity verification report for IEC 61010-2-045:2000 — Particular requirements for washer disinfectors used in medical, pharmaceutical, veterinary and laboratory fields. This document is a Technical Report that provides a standardized conformity‑verification (test) report and associated forms to record verification of compliance with the relevant IEC safety requirements.

Abstract

This Technical Report supplies a conformity verification report (template forms, tables and guidance) intended to assist test laboratories, manufacturers and conformity assessment bodies in documenting tests and recording whether washer‑disinfectors meet the requirements of IEC 61010‑2‑045:2000 and the referenced versions of IEC 61010‑1. It is informative in nature (a TR) and is not itself an International Standard. The report includes test record tables, lists of attached documents, test‑equipment lists and fields for signatures and approval.

General information

• Status: Withdrawn (technical report; withdrawn from IEC catalogue).
• Publication date: 25 April 2003 (Edition 1.0).
• Publisher: International Electrotechnical Commission (IEC), Technical Committee TC 66.
• ICS / categories: 19.080, 71.040.10 (Safety of measuring, control and laboratory equipment / sterilizers and washer‑disinfectors).
• Edition / version: Edition 1.0 (2003).
• Number of pages: 62 pages (electronic PDF).

Scope

The report is intended to be used when verifying conformity of washer‑disinfectors used in medical, pharmaceutical, veterinary and laboratory fields against the particular safety requirements of IEC 61010‑2‑045:2000 and the referenced IEC 61010‑1 editions/amendments. It covers the documentation and record‑keeping side of type testing/verification: the test report layout, identification of the equipment under test, test procedures employed, procedure deviations, non‑standard methods, attached documents, test‑equipment list and approval sign‑offs. The TR does not itself set new safety requirements beyond those in the referenced standards.

Key topics and requirements

• Conformity verification report template: standardized forms for test identification, signatures, approvals and summary statements.
• Test procedure and deviation documentation: fields to record test methods, deviations and non‑standard methods.
• Reference to normative requirements: links the report to IEC 61010‑2‑045:2000 and IEC 61010‑1 (and its amendments).
• Tables for attached documents and test equipment (calibration dates, equipment IDs).
• Fields covering installation/overvoltage category, pollution degree, environmental ratings and intended operating conditions to ensure correct interpretation of test results.

Typical use and users

Primary users are manufacturers of washer‑disinfectors, independent test laboratories, notified bodies/conformity assessment organizations, and regulatory or quality managers who need a standardised test report for documenting compliance with IEC safety requirements. The TR is used as a documentation aid during type testing, routine verification, and pre‑market conformity assessments where IEC 61010 series requirements apply.

Related standards

Directly related: IEC 61010‑2‑045:2000 (Particular requirements for washer disinfectors) and IEC 61010‑1 (General requirements for measurement, control and laboratory electrical equipment). IEC 61010‑2‑045:2000 has since been superseded/replaced in IEC catalogues by later Part 2 documents (for example IEC 61010‑2‑040 for sterilizers and washer‑disinfectors in later revisions). Washer‑disinfector performance and process requirements are also addressed in the ISO 15883 series (washer‑disinfectors), which is commonly referenced alongside IEC safety requirements for medical device applications.

Keywords

washer‑disinfector, conformity verification report, test report template, IEC 61010, IEC TR 61010‑3‑045, medical device equipment safety, TC 66, verification forms, test equipment list, installation category, pollution degree.

FAQ

Q: What is this standard?

A: It is a Technical Report (IEC TR 61010‑3‑045:2003) providing a conformity verification report and related forms for documenting tests and verification of washer‑disinfectors against IEC 61010 safety requirements. It is informative (a TR) rather than a normative International Standard.

Q: What does it cover?

A: It covers the format and content of a conformity verification report: identification of the equipment under test, test procedures and any deviations, lists of attached documents, test equipment calibration records, approval signatures and other fields required to record whether equipment meets the referenced IEC requirements. It does not itself introduce new safety requirements.

Q: Who typically uses it?

A: Manufacturers of washer‑disinfectors, test laboratories, notified/conformity assessment bodies, and regulatory or compliance teams who need a standardized way to record testing and conformity results to IEC 61010 series requirements.

Q: Is it current or superseded?

A: The TR was published in 2003 and is shown in IEC catalogues as withdrawn (withdrawal recorded in IEC metadata). The particular Part 2 standard it supports (IEC 61010‑2‑045:2000) has also been replaced in later IEC work by other Part‑2 documents (for example IEC 61010‑2‑040 for sterilizers and washer‑disinfectors in later revisions). Users should consult current IEC and ISO documents (e.g., the ISO 15883 series and current IEC 61010 Part 2 documents) for up‑to‑date normative requirements.

Q: Is it part of a series?

A: Yes — it is part of the IEC 61010 family of publications (safety requirements for electrical equipment for measurement, control and laboratory use). The TR sits under the IEC 61010‑3 (reports and guidance) subgroup and specifically supports the Part 2 document for washer‑disinfectors.

Q: What are the key keywords?

A: Washer‑disinfector, conformity verification, test report, IEC 61010, medical equipment safety, technical report, test equipment list, verification template.