laser medical equipment

laser medical equipment, Total:99 items.

The international standard classification for "laser medical equipment" includes: Therapy equipment , Ophthalmic equipment , Generalities. Terminology. Standardization. Documentation (Vocabularies) .

The Chinese standard classification for "laser medical equipment" includes: Medical ultrasound, laser, high-frequency instrument and equipment , Physiotherapy and TCM instrument and equipment , Medical radiographic equipment , Medical optical instrument and endoscope .

Professional Standard - Medicine

YY 0844-2011 Laser therapeutic equipment—Pulsed carbon dioxide laser treating instrument
YY 0845-2011 Laser therapeutic equipment—Diode laser equipment for photodynamic therapy
YY 0789-2024 Laser therapeutic equipment-Q-switched ophthalmic laser equipment
YY 1289-2016 Laser treating equipment―Ophthalmic semiconductor laser photocoagulators
YY 0599-2024 Laser therapeutic equipment - Excimer laser cornea ametropia equipment
YY 0846-2011 Laser therapeutic equipment—Ho:YAG laser equipment
YY 1300-2016 Therapeutic laser equipment―Pulsed Nd:YAG laser equipment for therapy
YY 0307-2022 Laser therapeutic equipment-Nd: YAG Laser Equipment
YY 0983-2016 Therapeutic laser equipment―Ruby Laser equipment for therapy
YY 1475-2016 Laser therapeutic equipment―Q-Switched Nd:YAG laser equipment
YY 0599-2015 Therapeutic laser equipment―Excimer laser cornea ametropia cure system
YY/T 0844-2011 Laser therapeutic equipment―Pulsed carbon dioxide laser treating instrument
YY 1301-2016 Therapeutic laser equipment―Er:YAG laser equipment for therapy

General Administration of Quality Supervision, Inspection and Quarantine of the People's Republic of China

GB/T 12257-2023 Laser therapeutic equipment—He-Ne laser equipment
GB/T 11748-2023 Laser therapeutic equipment—Carbon dioxide laser equipment
GB 9706.20-2000 Medical electrical equipment--Part 2:Particular requirements for the safety of diagnostic and therapeutic laser equipment

国家药监局

YY 1289-2022 Laser treatment equipment - Ophthalmic laser photocoagulator
YY 9706.257-2021 Medical electrical equipment—Part 2-57:Particular requirements for the basic safety and essential performance of non-laser light source equipment intended for therapeutic,diagnostic,monitoring and cosmetic/aesthetic use
YY/T 1751-2020 Therapeutic laser equipment—Laser diode irradiation therapeutic equipment for nasal cavity

Group Standards of the People's Republic of China

T/SXS 010-2023 Medical fine tube laser cutting machine

Shaanxi Provincial Standard of the People's Republic of China

DB61/T 1208-2018 Inspection specification for in-use medical laser equipment

未注明发布机构

CSA Z386-2020 Safe use of lasers in health care
DIN EN IEC 62667:2020 Medical electrical devices – Medical light ion irradiation devices – Apparatus quality characteristics (IEC 62667:2017)

British Standards Institution (BSI)

BS IEC 60825-8:2000 Safety of laser products - Guidelines for the safe use of medical laser equipment
BS EN 60601-2-22:1996 Medical electrical equipment - Particular requirements for safety - Specification for diagnostic and therapeutic laser equipment
20/30378652 DC BS ISO 22248. Lasers and laser-related equipment. Test methods for laser-induced damage threshold. Classification of medical beam delivery systems
BS EN 60601-2-22:2013 Medical electrical equipment. Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment
BS EN ISO 14971:2007 Medical devices - Application of risk management to medical devices
BS EN 62366:2008 Medical devices - Application of usability engineering to medical devices

International Electrotechnical Commission (IEC)

IEC TR 60825-8:1999 Safety of laser products - Part 8: Guidelines for the safe use of medical laser equipment
IEC 60601-2-22:1995 Medical electrical equipment - Part 2: Particular requirements for the safety of diagnostic and therapeutic laser equipment
IEC 60601-2-22:2007/AMD1:2012 Medical electrical equipment - Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment

RU-GOST R

GOST R 57086-2016 Medical electrical equipment. Devices for laser lithotripsy. Technical requirements for governmental purchases
GOST R 50267.22-2002 Medical electrical equipment. Part 2. Particular requirements for the safety of diagnostic and therapeutic laser equipment

Korean Agency for Technology and Standards (KATS)

KS C IEC 60825-8-2013(2019) Safety of laser products ― Part 8: Guidelines for safe use of medical laser equipment
KS C IEC 60825-8:2013 Safety of laser products ― Part 8: Guidelines for safe use of medical laser equipment
KS C IEC 60825-8:2002 Safety of laser products-Part 8:Guidelines for safe use of medical laser equipment
KS B ISO 11253-2015(2020) Lasers and laser-related equipment ― Laser device ― Mechanical interfaces
KS B ISO 11253-2020 Lasers and laser-related equipment ― Laser device ― Mechanical interfaces
KS B ISO 11252:2020 Lasers and laser-related equipment — Laser device —Minimum requirements for documentation
KS C IEC 60825-8-2019 Safety of laser products ― Part 8: Guidelines for safe use of medical laser equipment

SCC

CAN/CSA-Z386-1992 Laser Safety in Health Care Facilities
CSA Z386-2001 Laser Safety in Health Care Facilities
CAN/CSA-C22.2 No.60601-2-22-2001(C2005) Electromedical devices - Part 2: Particular safety rules for laser therapeutic and diagnostic devices
CAN/CSA-C22.2 No.601.2.22-1994 Electromedical devices - Part 2: Particular safety rules for laser therapeutic and diagnostic devices
DANSK DS/ISO 22248:2024 Lasers and laser-related equipment – Test methods for laser-induced damage threshold – Classification of medical beam delivery systems
BS EN 60601-2-22:1993 Medical electrical equipment. Particular requirements for safety-Specification for diagnostic and therapeutic laser equipment
DIN EN ISO 22248 E:2024 Draft Document - Lasers and laser-related equipment - Test methods for laser-induced damage threshold - Classification of medical beam delivery systems (ISO 22248:2020); German and English version prEN ISO 22248:2024
CAN/CSA Z386-1992 Laser Safety in Health Care Facilities
UNE-EN 60601-2-22:1997 MEDICAL ELECTRICAL EQUIPMENT. PART 2: PARTICULAR REQUIREMENTS FOR SAFETY OF DIAGNOSTIC AND THERAPEUTIC LASER EQUIPMENT.
IEC 60601-2-22:1992 Medical electrical equipment - Part 2: Particular requirements for the safety of diagnostic and therapeutic laser equipment
CAN/CSA-C22.2 No.60601-2-22-2001(R2005) Medical Electrical Equipment - Part 2: Particular Requirements for the Safety of Diagnostic and Therapeutic Laser Equipment
BS IEC 60825-8:1999 Safety of laser products-Guidelines for the safe use of medical laser equipment
CSA Z386-2014(R2019) Safe use of lasers in health care
CAN/CSA 601.2.22-1994 Medical Electrical Equipment - Part 2: Particular Requirements for the Safety of Diagnostic and Therapeutic Laser Equipment (Adopted IEC 601-2-22:1992 with modifications)
NS-ISO 11252:1993 Lasers and laser-related equipment - Laser device - Minimum requirements for documentation
LIA Z136.3-2011 Safe Use of Lasers in Health Care Facilities
AS/NZS 4173:1994 Guide to the safe use of lasers in health care
CSA Z386-2008(R2013) Safe Use of Lasers in Health Care Facilities
LIA Z136.3-2018 Safe Use of Lasers in Health Care Facilities
LIA Z136.3-2005 Safe Use of Lasers in Health Care Facilities
AS/NZS 3200.2.22:1993 Approval and test specification - Medical electrical equipment, Part 2.22: Particular requirements for safety - Diagnostic and therapeutic laser equipment
DANSK DS/EN ISO 11252:2013 Lasers and laser-related equipment - Laser device - Minimum requirements for documentation

International Organization for Standardization (ISO)

ISO 22466:2021 Traditional Chinese medicine - Laser acupoint devices
ISO 15223-1:2021/CD Amd 1:2024 Medical devices
ISO/CD 20417:2024 Medical devices
ISO 22248:2020 Lasers and laser-related equipment - Test methods for laser-induced damage threshold - Classification of medical beam delivery systems
ISO/DIS 21254-1:2024 Lasers and laser-related equipment

German Institute for Standardization

DIN EN 60601-2-22:1996 Medical electrical equipment - Part 2: Particular requirements for the safety of diagnostic and therapeutic laser equipment (IEC 60601-2-22:1995); German version EN 60601-2-22:1996
DIN EN ISO 22248:2024 Lasers and laser-related equipment - Test methods for laser-induced damage threshold - Classification of medical beam delivery systems (ISO 22248:2020); German and English version prEN ISO 22248:2024
DIN EN 62366:2008 Medical devices - Application of usability engineering to medical devices (IEC 62366:2007); German version EN 62366:2008
DIN EN ISO 11252:2014-02 Lasers and laser-related equipment - Laser device - Minimum requirements for documentation (ISO 11252:2013); German version EN ISO 11252:2013

CZ-CSN

CSN EN 60601-2-22-1994 Medical electrical equipment.Part 2:Particular requirements for the safety of diagnostic and therapeutic laser equipment

Association Francaise de Normalisation

NF C74-309:1973 ELECTROMEDICAL EQUIPMENT ACTINOLOGY APPARATUS
NF EN IEC 62667:2018 Medical electrical devices - Light ion beam medical devices - Performance characteristics
NF C74-341:1996 Medical electrical equipment. Part 2: particular requirements for the safety of diagnostic and therapeutic laser equipment
NF EN 60601-2-57:2012 Medical electrical devices - Part 2-57: particular requirements for the basic safety and essential performance of non-laser light source devices intended for therapeutic, diagnostic, monitoring, etc. uses
NF C74-054:2008 Medical devices - Application of usability engineering to medical devices.

GSO

BH GSO ISO 22466:2023 Traditional Chinese medicine — Laser acupoint devices
GSO ISO 22466:2023 Traditional Chinese medicine — Laser acupoint devices
OS GSO ISO 11252:2011 Lasers and laser-related equipment - Laser device - Minimum requirements for documentation

Lithuanian Standards Office

LST EN 60601-2-22-2000 Medical electrical equipment. Part 2: Particular requirements for the safety of diagnostic and therapeutic laser equipment (IEC 60601-2-22:1995)

VN-TCVN

TCVN 7303-2-22-2005 Medical electrical equipment.Part 2-22: Particular requirements for the safety of diagnostic and therapeutic laser equipment

BE-NBN

NBN-EN 60601-2-22-1994 Medical electrical equipment. Part 2: Particular requirements for the safety of diagnostic and therapeutic laser equipment

European Committee for Standardization (CEN)

EN 60601-2-22:1992 Medical electrical equipment; part 2: particular requirements for the safety of diagnostic and therapeutic laser equipment (IEC 601-2-22:1992)
EN 31253:1994 Lasers and Laser-Related Equipment - Laser Device - Mechanical Interfaces (ISO 11253 : 1993)

CENELEC - European Committee for Electrotechnical Standardization

EN 60601-2-22:1996 Medical Electrical Equipment - Part 2: Particular Requirements for the Safety of Diagnostic and Therapeutic Laser Equipment

European Committee for Electrotechnical Standardization（CENELEC）

EN 60601-2-22:2013 Medical electrical equipment - Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment

SE-SIS

SIS SS IEC 601-2-10:1988 Medical electrical equipment — Particular requirements for the safety of nerve andmuscle stimulators

NZ-SNZ

AS/NZS 4173:2004 Guide to the Safe Use of Lasers in Health Care

Institute of Electrical and Electronics Engineers (IEEE)

IEEE P1073.1.3.5/D04:2000 Standard for Medical Device Communications - Medical Device Data Language (MDDL) Virtual Medical Device, Specialized - Defibrillator Device

Standard Association of Australia （SAA）

AS/NZS 4173:2018 Safe use of lasers and intense light sources in health care
AS IEC 60601.2.22:2014 Medical electrical equipment, Part 2.22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment

IN-BIS

IS 13709-1993 Medical electrical equipment. Dental x-ray equipment. Radiation safety

Danish Standards Foundation

DS/EN ISO 11252:2013 Lasers and laser-related equipment - Laser device - Minimum requirements for documentation

KR-KS

KS B ISO 11252-2020 Lasers and laser-related equipment — Laser device —Minimum requirements for documentation

American National Standards Institute （ANSI)

ANSI/AAMI/IEC 62366:2007 Medical devices - Application of usability engineering to medical devices
ANSI Z136.3-2011 Standard for Safe Use of Lasers in Health Care

Indonesia Standards

SNI IEC 60601-2-22:2010 Medical electrical equipment -Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment