If you have difficulty in submitting comments on draft standards you can use a commenting template and email it to admin.start@bsigroup.com. The commenting template can be found here.

We use cookies to give you the best experience and to help improve our website

Find out what cookies we use and how to disable them

PNW TS 62A-1712 ED1: Part 4-1: Guidance and interpretation – Medical electrical equipment and medical electrical systems employing a level of autonomy

Source:
IEC
Committee:
CH/62 - Medical equipment, software, and systems
Categories:
Information management | Standardization. General rules
Comment period start date:
Comment period end date:

Comment by:

Scope

This document provides guidance for classifying LEVEL OF AUTONOMY (LOA) in MEDICAL ELECTRICAL EQUIPMENT, MEDICAL ELECTRICAL SYSTEM or MEDICAL DEVICE SOFTWARE. Those types of MEDICAL DEVICE SOFTWARE that are not in scope of the IEC 60601 series of medical s tandards, can also make use of this document.

This document also provides guidance on:

– Methodologies to perform RISK MANAGEMENT PROCESS, USABILITY ENGINEERING and SOFTWARE LIFECYCLE PROCESSES for ME EQUIPMENT, ME SYSTEM, MEDICAL DEVICE SOFTWARE with an LOA;

– Considerations of BASIC SAFETY and ESSENTIAL PERFORMANCE for ME EQUIPMENT, ME SYSTEM, MEDICAL DEVICE SOFTWARE with an LOA; Unless specified otherwise, this document considers ME EQUIPMENT and ME SYSTEM together.

The MANUFACTURER of an ME EQUIPMENT or ME SYSTEM with an LOA is expected to design and manufacture an ME EQUIPMENT or ME SYSTEM that fulfils its INTENDED USE and does not have unacceptable RISK throughout its LIFE-CYCLE.

This document provides guidance to help the medical MANUFACTURER in complying with the requirements of IEC 60601-1:2005 and IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020 for ME EQUIPMENT and ME SYSTEM with an LOA.

The document is also intended as guidance for future standard writers.

There are no prerequisites to this document.

Purpose

The IEC TR 60601-4-1 was published some years ago. Due to IEC administrative changes the TR standards need to be transformed into TS standards. Level of autonomy is an important term and concept for all the IEC TC 62 sub-committees standards.

Comment on proposal

Required form fields are indicated by an asterisk (*) character.

Discard

Please email further comments to: debbie.stead@bsigroup.com

Follow standard

You are now following this standard. Weekly digest emails will be sent to update you on the following activities:

You can manage your follow preferences from your Account. Please check your mailbox junk folder if you don't receive the weekly email.

Unfollow standard

You have successfully unsubscribed from weekly updates for this standard.

Error