ISO 10936-1:2017
(Main)Optics and photonics - Operation microscopes - Part 1: Requirements and test methods
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
- 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
- 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.
Frequently Asked Questions
ISO 10936-1:2017 is a standard published by the International Organization for Standardization (ISO). Its full title is "Optics and photonics - Operation microscopes - Part 1: Requirements and test methods". This standard covers: 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.
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.
ISO 10936-1:2017 is classified under the following ICS (International Classification for Standards) categories: 11.040.30 - Surgical instruments and materials; 37.020 - Optical equipment. The ICS classification helps identify the subject area and facilitates finding related standards.
ISO 10936-1:2017 has the following relationships with other standards: It is inter standard links to ISO 10936-1:2000. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
ISO 10936-1:2017 is available in PDF format for immediate download after purchase. The document can be added to your cart and obtained through the secure checkout process. Digital delivery ensures instant access to the complete standard document.
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
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the requester.
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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
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This document was prepared by Technical Committee ISO/TC
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