YY/T 1975-2025Far infrared magnetic therapy patch (bag) (English PDF)
远红外磁疗贴(袋)
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Issued by
NMPA
Level / Type
Industry · Recommended
Issue date
June 18, 2025
Implementation date
July 1, 2026
Scope
YY/T 1975-2025 is the English-translated version of 远红外磁疗贴(袋).
YY/T 1975 is the product standard for the far infrared magnetic therapy patch, a physical therapy product sold in large volumes in China and increasingly exported. It specifies the classification and the requirements for far infrared magnetic therapy patches and bags, and describes the corresponding test methods. It applies to patch products that contain both far infrared materials and magnetic materials, and excludes products falling outside that description. Because the therapeutic claim rests on two measurable physical properties, the infrared emission characteristics and the magnetic field, the standard is what turns a wellness product into a regulated device with verifiable parameters. For a manufacturer or an exporter of therapy patches, this is the Chinese standard the product has to meet and the reference for what the label may claim.
Document preview — YY/T 1975-2025
National Standard of the People's Republic of China
- ICS
- 11.040.60
- Classification
- C42
Issued by: National Medical Products Administration
Contents
- 1.Scope1
- 2 Normative References1
- 3.Terms and Definitions1
- 4.Classification1
- 5 Requirements2
- 5.1 Dimensions2
- 5.2 Appearance2
- 5.3 Holding power2
- 5.4 Peel strength2
- 5.5 Connection strength2
- 5.6 Fixation of Magnetic Materials2
- 5.7 Normal Emissivity2
- 5.8 Magnetic induction intensity2
- 5.9 Heavy metals (calculated as lead ions)2
- 5.10 Biocompatibility2
- 5.11 Residue2
- 5.12 External Marker3
- 5.13 User Manual3
- 6.Test Methods3
- 6.1 Dimensions3
- 6.2 Appearance3
- 6.3 Tackiness3
- 6.4 Peel strength3
- 6.5 Connection strength3
- 6.6 Fixation of Magnetic Materials3
- 6.7 Normal emissivity3
- 6.8 Magnetic induction intensity3
- 6.9 Heavy metals (calculated as lead ions)4
- 6.10 Biocompatibility4
- 6.11 Residue4
- 6.12 External Marker4
- 6.13 User Manual4
Foreword
This document complies with the provisions of GB/T 1.1-2020 "Standardization Work Guidelines Part
1.Structure and Drafting Rules of Standardization Documents". Drafting. Please note that some content in this document may involve patents. The issuing organization of this document assumes no responsibility for identifying patents. This document was proposed by the National Medical Products Administration. This document is under the jurisdiction of the Physical Therapy Equipment Subcommittee of the National Technical Committee on Standardization of Medical Electrical Appliances (SAC/TC10/SC4). This document was drafted by: Henan Chaoya Medical Equipment Co., Ltd., Hubei Provincial Institute of Medical Device Quality Supervision and Inspection, and Henan Chaoya Medical Equipment Co., Ltd. Asia New Materials Co., Ltd., Jiangxi Provincial Medical Device Testing Center, Jilin Provincial Medical Device Inspection and Research Institute, Jiangxi Aici Biotechnology Co., Ltd. company. The main drafters of this document are. Zhang Yachao, Cao He, Li Ling, Zeng Ming, Cai Aihua, Hou Donghui, Cao Yu, Xu Yanan, Sun Jimin, Wang Jingnan, and Liu Lu. Far-infrared magnetic therapy patch (bag)
1 Scope
YY/T 1975 is the product standard for the far infrared magnetic therapy patch, a physical therapy product sold in large volumes in China and increasingly exported. It specifies the classification and the requirements for far infrared magnetic therapy patches and bags, and describes the corresponding test methods. It applies to patch products that contain both far infrared materials and magnetic materials, and excludes products falling outside that description. Because the therapeutic claim rests on two measurable physical properties, the infrared emission characteristics and the magnetic field, the standard is what turns a wellness product into a regulated device with verifiable parameters. For a manufacturer or an exporter of therapy patches, this is the Chinese standard the product has to meet and the reference for what the label may claim.
This document specifies the classification and requirements for far-infrared magnetic therapy patches (bags) and describes the corresponding test methods. This document applies to adhesive patch products containing far-infrared and magnetic materials. This document does not apply to.
---Contains chemical components, traditional Chinese medicinal materials (or natural plants) and their extracts, etc., the components of which exert pharmacological, immunological or metabolic effects. Used patch-type products;
---Contains chemical components, traditional Chinese medicinal materials (or natural plants) and their extracts, etc., and cannot prove that it does not exert pharmacological, immunological, or metabolic effects. Patch products with therapeutic effects.
2 Normative references
The contents of the following documents, through normative references within the text, constitute essential provisions of this document. Dated citations are not included. For references to documents, only the version corresponding to that date applies to this document; for undated references, the latest version (including all amendments) applies. This document.
GB/T 14233.1-2022 Medical infusion, transfusion and injection equipment test methods - Part
3 Terms and Definitions
The following terms and definitions apply to this document.
3.1 The main material components (far-infrared materials and magnetic materials, without any pharmaceutical ingredients) are placed in an inner bag and sealed in a certain proportion or with... After the medical adhesive/paste (such as hot melt adhesive/plaster, etc.) is mixed evenly, it is spread onto a substrate (such as non-woven fabric/plain fabric, etc.) and the far-infrared and magnetic properties are utilized. The effects of substances on organisms, and patch-type products used as adjunctive treatments for patients.
3.2 normal emissivity The emissivity of the working surface along the normal direction, i.e., the emitted radiation intensity within a specific wavelength range and temperature, is comparable to that of an ideal blackbody at the same wavelength and temperature. The ratio of the intensity of radiation emitted at a given temperature.
Note. The working surface mentioned in this document refers to the surface of the far-infrared magnetic therapy patch (bag) that comes into contact with the patient when in use.
4.Classification Based on usage, they are divided into non-adhesive and adhesive types. Adhesive types generally include far-infrared materials, magnetic materials, medical adhesives/pastes, substrates, and... Release materials; non-adhesive types generally include far-infrared materials, magnetic materials, and fixing devices.
......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 8 pages — is available in the English PDF.
Referenced standards
Normative references
- GB/T 14233.1-2022Test methods for infusion, transfusion, injection equipments for medical use - Part 1: Chemical analysis methods
- GB/T 16886.1Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
- YY/T 0148-2006Medical adhesive tapes - General requirements
Similar standards
YY 0950|YY/T 1095|YY 0900|YY/T 1979|YY/T 1976
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Related Standards
GB/T 14233.1-2022 — Test methods for infusion, transfusion, injection equipments for medical use - Part 1: Chemical analysis methods
GB/T 16886.1-2022 — Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
GB/T 16886.10-2024 — Biological evaluation of medical devices - Part 10: Tests for skin sensitization
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YY/T 1975-2025
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