ISO 16142-1-2016 PDF

Full title and description

Medical devices — Recognized essential principles of safety and performance of medical devices — Part 1: General essential principles and additional specific essential principles for all non‑IVD medical devices and guidance on the selection of standards. This document provides recognized essential principles and identifies standards and guides that can be used to demonstrate conformity of non‑IVD medical devices with those principles.

Abstract

ISO 16142‑1:2016 presents the general essential principles of safety and performance applicable to medical devices and additional specific essential principles relevant to medical devices other than in vitro diagnostics (non‑IVD). It also gives guidance to manufacturers and conformity assessment bodies on selecting relevant standards and guides that support conformity assessment activities. The document was published as Edition 1 in March 2016.

General information

• Status: Withdrawn (documented as withdrawn by ISO).
• Publication date: March 2016.
• Publisher: International Organization for Standardization (ISO).
• ICS / categories: 11.040.01 — Medical equipment in general.
• Edition / version: Edition 1 (2016).
• Number of pages: 47 pages.

(Core bibliographic and lifecycle metadata as recorded by ISO for ISO 16142‑1:2016.)

Scope

ISO 16142‑1:2016 applies to medical devices other than in vitro diagnostic (IVD) medical devices. It identifies and describes the general essential principles of safety and performance that apply across medical devices and the additional specific essential principles that are relevant to design and manufacture of non‑IVD devices. The document also gives guidance on selecting standards and guides that can be used to demonstrate conformity to those essential principles.

Key topics and requirements

• Definition and description of the general essential principles of safety and performance for medical devices.
• Additional specific essential principles relevant to non‑IVD medical devices (design and manufacturing considerations).
• Guidance on how to select harmonized or recognized standards and guides to support conformity assessment.
• Guidance intended for manufacturers, standards bodies, regulatory authorities and conformity assessment bodies.
• Notes on documenting applicability and exclusion of particular principles during device design and manufacture.

Typical use and users

Intended users include medical device manufacturers, standards-development organizations, regulatory authorities, and conformity assessment bodies. Typical uses are selecting appropriate standards to demonstrate conformity with essential principles, preparing technical documentation, and guiding regulatory/conformity assessment strategies for non‑IVD devices.

Related standards

ISO 16142‑1:2016 updated and superseded earlier ISO/TR 16142 technical reports and is part of a broader ISO 16142 series approach; ISO 16142‑2:2017 covers analogous essential principles and guidance for IVD medical devices. Note that ISO has recorded lifecycle changes to these documents (both parts have been recorded as withdrawn in ISO metadata).

Keywords

medical device safety, essential principles, conformity assessment, non‑IVD devices, standards selection, ISO 16142, regulatory guidance, technical documentation

FAQ

Q: What is this standard?

A: ISO 16142‑1:2016 is an ISO International Standard that sets out recognized essential principles of safety and performance for medical devices (specifically non‑IVD devices) and provides guidance on selecting standards to demonstrate conformity with those principles.

Q: What does it cover?

A: It covers the general essential principles of safety and performance that apply across medical devices, additional specific principles relevant to non‑IVD devices, and guidance for selecting standards and guides to be used in conformity assessment and technical documentation.

Q: Who typically uses it?

A: Manufacturers of medical devices (non‑IVD), standards-development organizations, regulatory authorities and conformity assessment bodies use it to inform selection of standards and to support regulatory submissions and compliance strategies.

Q: Is it current or superseded?

A: ISO records show ISO 16142‑1:2016 as withdrawn in its lifecycle metadata. Users should consult their national/regulatory bodies or ISO’s current catalogue to confirm the current recognized guidance and to identify any successor or replacement documents before relying on it for regulatory decisions.

Q: Is it part of a series?

A: Yes — it forms part of the ISO 16142 series approach: ISO 16142‑1 focuses on non‑IVD medical devices, and ISO 16142‑2 was published for IVD medical devices. Earlier ISO/TR 16142 technical reports were revised by these parts.

Q: What are the key keywords?

A: Key keywords include essential principles, safety and performance, conformity assessment, standards selection, medical devices, non‑IVD, technical documentation, and regulatory guidance.