ISO 10936-1:2017

Optics and photonics - Operation microscopes - Part 1: Requirements and test methods

ISO 10936-1:2017 specifies requirements and refers to test methods for operation microscopes used for observation during surgical operation and treatment of patients. It does not apply to accessories, e.g. photographic cameras. NOTE Specific requirements with regard to optical radiation hazards from operation microscopes used in ocular surgery are given in ISO 10936‑2.

Optique et photonique — Microscopes chirurgicaux — Partie 1: Exigences et méthodes d'essai

General Information

• Status: Published
• Publication Date: 25-Jul-2017
• ICS: 11.040.30 - Surgical instruments and materials
• ICS: 37.020 - Optical equipment
• Technical Committee: ISO/TC 172/SC 5 - Microscopes and endoscopes
• Drafting Committee: ISO/TC 172/SC 5/WG 9 - Optical performance of microscope components
• Current Stage: 9093 - International Standard confirmed
• Start Date: 14-Sep-2022
• Completion Date: 13-Dec-2025

Relations

• Revises: ISO 10936-1:2000 - Optics and optical instruments - Operation microscopes - Part 1: Requirements and test methods
• Effective Date: 04-Nov-2015

Overview

ISO 10936-1:2017 is an international standard published by the International Organization for Standardization (ISO) that specifies the requirements and test methods for operation microscopes used during surgical operations and patient treatments. Operation microscopes are specialized stereomicroscopes designed to provide surgeons with high precision optical observation. This standard ensures the quality, safety, and performance of these critical optical devices, except for accessories like photographic cameras. For light hazard concerns related to ocular surgery, ISO 10936-2 covers additional requirements.

Key Topics

• Optical and Mechanical Requirements: ISO 10936-1 defines stringent tolerances for magnification accuracy, left-right optical system alignment, focusing plane shifts, resolving power, imaging rotation differences, interpupillary distance, and dioptre adjustments to guarantee precise and reliable visualization during surgery.
• Environmental Conditions: The operation microscope must meet environmental standards aligned with IEC 60601-1, ensuring the device’s durability and proper performance under typical hospital operating room conditions.
• Safety: Safety requirements follow IEC 60601-1 to ensure the microscope’s electrical and mechanical safety, minimizing risks to both patients and medical personnel.
• Testing Protocols: The standard prescribes type testing methods for evaluating optical-mechanical specs, environmental resilience (per ISO 9022), and safety compliance.
• Marking and Identification: Operation microscopes must have permanent markings compliant with IEC 60601-1 for clear identification and traceability.

Applications

ISO 10936-1:2017 applies specifically to operation microscopes used in surgical environments, enhancing precision in:

• Neurosurgery
• Otolaryngology (ENT surgery)
• Microsurgery
• Dentistry
• Plastic and reconstructive surgery
• General surgical treatments demanding magnified visualization

By adhering to ISO 10936-1, manufacturers and healthcare providers ensure that operation microscopes deliver consistent optical performance and mechanical reliability, which are crucial for patient safety and successful surgical outcomes.

Related Standards

• ISO 10936-2: Addresses optical radiation hazards linked to operation microscopes in ocular surgery, complementing the general requirements of ISO 10936-1.
• IEC 60601-1: Specifies general safety and performance criteria for medical electrical equipment, referenced heavily for environmental and safety requirements.
• ISO 7944: Defines reference wavelengths utilized in optical instrument testing.
• ISO 8039: Covers values, tolerances, and symbols for magnification relevant to microscopes.
• ISO 9022: Provides environmental test methods ensuring device robustness under operating conditions.
• ISO 15227: Details testing protocols for stereomicroscopes, ensuring statistical accuracy and measurement precision.
• ISO 11883: Outlines marking requirements for stereomicroscopes, similar to those in operation microscopes.

---

Keywords: ISO 10936-1, operation microscopes, surgical microscopes, optical requirements, mechanical requirements, medical device standards, IEC 60601-1, test methods, surgical optics, photonics, medical equipment safety, microscope standards, optical testing, surgical visualization.

Standards Content (Sample)

INTERNATIONAL ISO
STANDARD 10936-1
Second edition
2017-08
Optics and photonics — Operation
microscopes —
Part 1:
Requirements and test methods
Optique et photonique — Microscopes chirurgicaux —
Partie 1: Exigences et méthodes d’essai
Reference number
©
ISO 2017
© ISO 2017, Published in Switzerland
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized otherwise in any form
or by any means, electronic or mechanical, including photocopying, or posting on the internet or an intranet, without prior
written permission. Permission can be requested from either ISO at the address below or ISO’s member body in the country of
the requester.
ISO copyright office
Ch. de Blandonnet 8 • CP 401
CH-1214 Vernier, Geneva, Switzerland
Tel. [phone]
Fax [phone]
[e-mail]
www.iso.org
ii © ISO 2017 – All rights reserved

Contents Page
Foreword .iv
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Requirements . 2
4.1 General . 2
4.2 Optical and mechanical requirements . 2
4.3 Environmental conditions . 2
4.4 Safety . 2
5 Test methods . 2
5.1 General . 2
5.2 Checking the optical and mechanical specifications . 2
5.3 Checking the environmental conditions . 2
5.4 Checking the safety. 2
6 Marking . 2
Bibliography . 4
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards
bodies (ISO member bodies). The work of preparing International Standards is normally carried out
through ISO technical committees. Each member body interested in a subject for which a technical
committee has been established has the right to be represented on that committee. International
organizations, governmental and non-governmental, in liaison with ISO, also take part in the work.
ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of
electrotechnical standardization.
The procedures used to develop this document and those intended for its further maintenance are
described in the ISO/IEC Directives, Part 1. In particular the different approval criteria needed for the
different types of ISO documents should be noted. This document was drafted in accordance with the
editorial rules of the ISO/IEC Directives, Part 2 (see www .iso .org/ directives).
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of
any patent rights identified during the development of the document will be in the Introduction and/or
on the ISO list of patent declarations received (see www .iso .org/ patents).
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation on the voluntary nature of standards, the meaning of ISO specific terms and
expressions related to conformity assessment, as well as information about ISO’s adherence to the
World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT) see the following
URL: w w w . i s o .org/ iso/ foreword .html.
This document was prepared by Technical Committee ISO/TC
...