IS 19355 : 2025 Unani Medicine - Glass Cup MIḤJAMA (Cupping Therapy) Device
| ICS 97.140, 81.040.100 | AYD 04 |
1 SCOPE
This standard outlines the requirements for a glass cup Miḥjama (Cupping therapy) device that functions through negative pressure. This standard includes specifications regarding the material used for the device, the pressure settings, sterilization or disinfection methods, sampling, packaging of the glass cupping device and methods for testing.
This standard applies to the single-use and multiple-use glass cupping devices.
NOTE - This standard does not apply to the suction pump used to create the negative pressure.
2 REFERENCES
The standards listed in Annex A contain provisions which, through reference in this text, constitute provision of this standard. At the time of publication, the editions indicated were valid. All standards are subject to revision, and parties to agreement based on this standard are encouraged to investigate the possibility of applying the most recent editions of the standards.
| IS No. | Title |
| IS 4426 : 2025 | Methods of sampling laboratory glassware (second revision) |
| IS 9806 : 2001 | Methods of test for and permissible limits of toxic materials released from ceramicware, vitreous enamelware, glassware and glass-ceramicware in contact with food (first revision) |
| IS/ISO 10993-18 : 2020 | Biological evaluation of medical devices: Part 18 Chemical characterization of medical device materials within a risk management process |
| IS/ISO 11135 : 2014 | Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices |
| IS/ISO 11137-1 : 2006 | Sterilization of health care products - Radiation: Part 1 Requirements for development, validation and routine control of a sterilization process for medical devices |
| IS 11539 : 2018/ISO 8113 : 2004 | Method of vertical load test for glass containers (first revision) |
| IS/ISO 11607-1 : 2019 | Packaging for terminally sterilized medical devices: Part 1 requirements for materials, sterile barrier systems and packaging systems (first revision) |
| IS/ISO 15223-1 : 2016 | Medical Devices - symbols to be used with medical device labels, labelling and information to be supplied: Part 1 General requirements (second revision) |
| IS/ISO 15223-2 : 2010 | Medical devices - Symbols to be used with medical device labels, labelling, and information to be supplied: Part 2 Symbol development, selection and validation |
| IS 17932 (Part 4) : 2024 | Biological evaluation of medical devices: Part 4 Physico-chemical morphological and topographical characterization of materials |
| IS 18219 : 2023/ISO 3585 : 1998 | Borosilicate glass 3.3 - Properties |
| IS 18319 : 2024/ISO 17665 : 2024 | Sterilization of health care products - Moist heat - Requirements for the development, validation and routine control of a sterilization process for medical devices (first revision) |
| IS 18750 (Part 1) : 2024 | Unani medicine - Glossary of terms: Part 1 Standardized terminology used for fundamental principles |
| IS 19085 : 2024 | Glass containers for homoeopathic pharmaceutical preparations - Specification |