IEC PAS 63077:2016

IEC PAS 63077 ®
Edition 1.0 2016-11
PUBLICLY AVAILABLE
SPECIFICATION
PRE-STANDARD
Good refurbishment practices for medical imaging equipment

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IEC PAS 63077 ®
Edition 1.0 2016-11
PUBLICLY AVAILABLE
SPECIFICATION
PRE-STANDARD
Good refurbishment practices for medical imaging equipment

INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
ICS 11.040.55 ISBN 978-2-8322-3761-8

– 2 – IEC PAS 63077:2016 © IEC 2016

CONTENTS
FOREWORD . 3

INTRODUCTION . 5

1 Scope . 6

2 Normative references . 6

3 Terms and definitions . 6

4 General requirements for refurbishment of used medical devices . 8

4.1 Quality management system . 8
4.2 Resource management . 8
4.3 Corrective and preventive action . 9
4.4 Customer complaints . 9
4.5 Production and service provision . 9
4.6 Control of non-conforming product . 9
4.7 Post-market surveillance process . 9
4.8 Document control . 9
4.9 Purchasing . 9
4.10 Control of design and design changes . 10
4.11 Risk management process . 10
5 Specific requirements for good refurbishment practice . 10
5.1 General . 10
5.2 Selection of medical imaging equipment for refurbishment . 10
5.3 Evaluating market access requirements . 10
5.4 Preparation for refurbishment, disassembly, packing, and shipment . 10
5.5 Planning . 11
5.6 Installation of safety updates (hardware/software) . 11
5.7 Performance and safety test . 11
5.8 Packing, shipment, and installation of refurbished medical imaging
equipment . 11
5.9 Record of refurbishment . 11
5.10 Refurbishment label . 11
Bibliography . 12

INTERNATIONAL ELECTROTECHNICAL COMMISSION

____________
GOOD REFURBISHMENT PRACTICES
FOR MEDICAL IMAGING EQUIPMENT
FOREWORD
1) The International Electrotechnical Commission (IEC) is a worldwide organization for standardization comprising

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A PAS is a technical specification not fulfilling the requirements for a standard, but made

available to the public.
IEC PAS 63077 has been processed by subcommittee 62B: Diagnostic imaging equipment, of
IEC technical committee 62: Electrical equipment in medical practice.
The text of this PAS is based on the This PAS was approved for
following document: publication by the P-members of the
committee concerned as indicated in
the following document
Draft PAS Report on voting
62B/1022/PAS 62B/1030/RVC
Following publication of this PAS, which is a pre-standard publication, the technical committee
or subcommittee concerned may transform it into an International Standard.

– 4 – IEC PAS 63077:2016 © IEC 2016

This PAS shall remain valid for an initial maximum period of 3 years starting from the

publication date. The validity may be extended for a single period up to a maximum of

3 years, at the end of which it shall be published as another type of normative document, or

shall be withdrawn.
INTRODUCTION
Keeping up with the latest innovations in medical technology often involves replacing

equipment in medical practice before it reaches the end of its expected service life. This is

because innovation cycles for medical technology are much shorter than the functional

lifecycle of capital equipment. As a result, a sustainable resource management model is

required: early replacement of installed medical imaging equipment by newer technology is

more economically feasible if the residual value of the existing medical imaging equipment is

utilized.
Conserving assets is a fundamental principle of ecological thinking in a recycling economy.

Several medical imaging equipment companies have already set up quality management
systems to refurbish used medical imaging equipment and have delivered this refurbished
equipment across the healthcare sector for many years. Refurbishment addresses the high
demand for affordable and reliable products. Customers of this used equipment are not only
small hospitals with limited budgets but also leading medical institutes. The EU and the US
represent by far the two largest markets for refurbished medical equipment. Refurbishment of
used medical imaging equipment is a well-established element of the healthcare economy.
If used medical imaging equipment is not accurately maintained according to requirements
defined by the manufacturer, it may result in additional risk for patients and operators.
Consequently, some countries have imposed bans on the importation of used medical imaging
equipment to protect public health. These bans fail to distinguish between quality-assured
refurbished medical imaging equipment and second-hand medical imaging equipment of
undefined quality, with the effect that patients may be denied access to the safe and
economical medical imaging equipment they need.
Safety and effectiveness are the most important aspects to consider with medical imaging
equipment, including used equipment. To ensure safety and effectiveness, used medical
imaging equipment has to be refurbished in a highly specialized and quality-assured way.

– 6 – IEC PAS 63077:2016 © IEC 2016

GOOD REFURBISHMENT PRACTICES
FOR MEDICAL IMAGING EQUIPMENT
1 Scope
This document describes and defines the process of refurbishment of used medical imaging
equipment and applies to the restoring of used medical imaging equipment to a condition of

safety and effectiveness comparable to that of new equipment. This restoration includes

actions such as repair, rework, software/hardware updates, and the replacement of worn parts
with original parts. This document enumerates the actions that must be performed and the
manner consistent with product specifications and service procedures required to ensure that
the refurbishment of medical imaging equipment is done without changing the finished
medical imaging equipment’s performa
...