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GB/T 30117.3-2019Photobiological safety of lamps and lamp systems -- Part 3: Guidelines for the safe use of intense pulsed light source equipment on humans (English PDF)

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Issued by

SAMR; SAC

Level / Type

National · Recommended

Issue date

October 18, 2019

Implementation date

May 1, 2020

Scope

GB/T 30117.3-2019 (Photobiological safety of lamps and lamp systems -- Part 3: Guidelines for the safe use of intense pulsed light source equipment on humans) is available as an English-translated PDF.

GB/T 30117.3-2019 — This Part of GB/T 30117 provides guidelines for the safe use of INTENSE PULSED LIGHT (IPL) source equipment in professional premises. This Part sets out the control measures recommended for the safety of recipients of IPL treatment, staff, service, maintenance personnel and others. Engineering controls which form part of the IPL equipment or the installation are also briefly described to provide an understanding of the general principles of protection.

Document preview — GB/T 30117.3-2019

National Standard of the People's Republic of China

Issued by: SAMR; SAC

Foreword...3
1 Scope and Object...5
1.1 Scope...5
1.2 Object...5
2 Normative References...5
3 Terms and Definitions...6
4 Responsibility for Safe Working Conditions...7
5 Risks from Exposure to IPL Optical Radiation...7
5.1 Risks to the eye...7
5.2 Skin burns...8
5.3 Scars...8
5.4 Hyper/hypo-pigmentation...8
5.5 Purpura...9
5.6 Unrecognized malignancies or premalignant conditions on the treatment site...9
5.7 Delicate anatomy or inappropriate treatment sites...9
5.8 Drug-induced photosensitivity...9
5.9 Contra-indicated CLIENT conditions...9
6 Causes of Risks...10
6.1 General...10
6.2 Operator errors...10
6.3 Poor CLIENT compliance...12
6.4 IPL OUTPUT variability from older equipment...12
6.5 Risks from other potential hazards...13
6.6 Cleansing and disinfecting...13
7 Risk Assessment...13
8 Education and Training...15
Annex A (Informative) Biological Effects, SKIN TYPES...17
Annex B (Informative) Personal Eye Protection...25
Annex C (Informative) IPL Technology, Classification...26
Annex D (Informative) Warning Sign...27
Annex E (Informative) Local Rules...28
Bibliography...33

Foreword

GB/T 30117 Photobiological Safety of Lamps and Lamp Systems consists of the following parts.

--- Part 1.General Requirements;

--- Part 2.Guidance on Manufacturing Requirements Relating to Non-Laser Optical

Radiation Safety;

--- Part 3.Guidelines for the Safe Use of Intense Pulsed Light Source Equipment on Humans;

--- Part 4.Measuring Methods;

--- Part 5.Image Projectors;

--- Part 6.Ultraviolet Lamps Products.

This Part is Part 3 of GB/T 30117.

This Part was drafted as per the rules specified in GB/T 1.1-2009.

This Part used translation method to equivalently adopt IEC TR 62471-3.2015 Photobiological

Safety of Lamps and Lamp Systems - Part 3.Guidelines for the Safe Use of Intense Pulsed

Light Source Equipment on Humans.

This Part made the following editorial modifications.

--- Change the explanatory phrase in "3.6 Responsible Person" in the international standard

into "NOTE";

--- Change the explanatory phrase in "5.9 Contraindications" in the international standard

from "Currently using photosensitizing drugs for treatment. See 5.9 for details of the

drugs" into "Currently using photosensitizing drugs for treatment. See 5.8 for details of

the drugs."

Please note some contents of this Document may involve patents. The issuing agency of this

Document shall not assume the responsibility to identify these patents.

This Part was proposed by China Machinery Industry Federation.

This Part shall be under the jurisdiction of National Technical Committee on Optical Radiation

Safety and Laser Equipment of Standardization Administration of China (SAC/TC 284).

Drafting organizations of this Part. Hangzhou Zhejiang University Sensing Instruments Co.,

Ltd.; Xiamen Institute of Measurement and Testing; Puyang Quality and Technical Supervision

Inspection and Testing Center; Zhejiang Smart Lighting Technology Co., Ltd.; People's

Liberation Army General Hospital; Wenzhou Medical University; Hangzhou Santai Testing

Photobiological Safety of Lamps and Lamp Systems - Part

3 Guidelines for the Safe Use of Intense Pulsed Light Source

Equipment on Humans

1 Scope and Object

1.1 Scope

This Part of GB/T 30117 provides guidelines for the safe use of INTENSE PULSED LIGHT

(IPL) source equipment in professional premises.

This Part sets out the control measures recommended for the safety of recipients of IPL

treatment, staff, service, maintenance personnel and others. Engineering controls which form

part of the IPL equipment or the installation are also briefly described to provide an

understanding of the general principles of protection.

1.2 Object

The object of this Part is to provide information which helps to protect persons from hazardous

exposure to optical radiation and other associated hazards by providing guidance on how to

establish safety measures and procedures.

NOTE. Although the manufacturers provide treatment information in their instructions for use, such

information may not be exhaustive or applicable to all CLIENT treatment conditions.

If IPLs are applied to patients in medical premises, the physician is deemed to be responsible

for all medical aspects of the treatment including his or her decisions about questions of

indication and contraindication such as found in Clauses 5 and 6.

2 Normative References

The following documents, in whole or in part, are normatively referenced in this document and

are indispensable for its application. For dated references, only the edition cited applies. For

undated references, the latest edition of the referenced document (including any amendments)

applies.

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This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — all pages — is available in the English PDF.

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