ISO 19611:2017 PDF

Traditional Chinese medicine — Air extraction cupping device

Название (английский):

ISO 19611:2017

Traditional Chinese medicine — Air extraction cupping device

Статус документа:: Действующий
Формат:: Электронный (PDF)
Количество страниц:: 9
Дата публикации:: 23 мая 2017 г.
Издание:: ISO IS 19611 edition 1 version 1
ICS:: 11.040.99

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Описание (английский):

ISO 19611:2017 specifies requirements for an air extraction cupping device which operates using negative pressure. This document includes requirements for the material, pressure, sterilization or disinfection, and packaging of the cupping device, as well as appropriate test methods. ISO 19611:2017 is applicable to single-use type and multiple-use type devices. ISO 19611:2017 does not apply to the suction pump used to create the negative pressure.

Технические детали

Технический комитет: ISO/TC 249 - Traditional Chinese medicine
SKU: ISO 19611:2017

Abstract

Overview

ISO 19611:2017 - Traditional Chinese medicine - Air extraction cupping device - defines safety, performance and packaging requirements for air extraction cupping devices that operate using negative pressure. The standard covers materials, dimensions, pressure performance, sterilization/disinfection, labelling and test methods, and applies to both single‑use and multiple‑use cupping cups. (The suction pump that creates negative pressure is excluded.)

Key topics and technical requirements

Scope & configuration
- Defines parts: body, air outlet and one‑way valve; specifies inner volume classes (e.g., 70 ±7 ml, 55 ±5.5 ml, 40 ±4.0 ml, 25 ±2.5 ml, 15 ±1.5 ml).
- Air outlet must include an outer diameter portion of at least 11 mm.
- Skin‑contacting edge must be rounded to prevent injury; transparency required to observe skin changes.
Performance
- Negative pressure resistance: device must resist a maximum instantaneous negative pressure (specified in the standard).
- Pressure maintenance: pressure must be maintained over time (standard requires limited pressure loss over 10 minutes).
- Mechanical stability: maintain pressure after impact testing (0.5 J ±0.05 J).
- Repeated disinfection resistance: multiple‑use devices must retain performance after repeated disinfection.
Biological safety
- Biological evaluation per ISO 10993 series. Required tests vary by type:
  - Both single‑use and multiple‑use: cytotoxicity and sensitization.
  - Single‑use (blood‑contact) additionally: intracutaneous reactivity, acute systemic toxicity, hemocompatibility.
  - Ethylene oxide (EO) residual testing when EO sterilization is used.
Sterilization & disinfection
- Single‑use devices: validated sterilization per ISO 11135 / ISO 11137‑1 / ISO 17665‑1.
- Multiple‑use devices: validated disinfection procedures per ISO 17664.
Packaging & labelling
- Primary package must be sealed, free of foreign matter, protect sterility/disinfection and show evidence of opening.
- Symbols and labelling follow ISO 15223‑1; secondary packaging must protect contents during transport/storage.

Applications and users

ISO 19611 is intended for:

Manufacturers and designers of cupping devices (product specification, testing and CE/market compliance).
Quality assurance, regulatory affairs and conformity assessment teams in medical device companies.
Sterilization and reprocessing specialists defining validated processes.
Healthcare providers, clinics and procurement teams that purchase single‑use or reusable cupping cups.
Test laboratories performing performance and biocompatibility testing.

Related standards

ISO 10993 (biological evaluation)
ISO 11135, ISO 11137‑1, ISO 17665‑1 (sterilization)
ISO 17664 (reprocessing information)
ISO 15223‑1 (symbols on labels)
ISO 11607‑1 (packaging for terminally sterilized devices)

Keywords: ISO 19611, air extraction cupping device, cupping therapy, traditional Chinese medicine, negative pressure, sterilization, biocompatibility, medical device packaging.

Overview

Key topics and technical requirements

Scope & configuration
- Defines parts: body, air outlet and one‑way valve; specifies inner volume classes (e.g., 70 ±7 ml, 55 ±5.5 ml, 40 ±4.0 ml, 25 ±2.5 ml, 15 ±1.5 ml).
- Air outlet must include an outer diameter portion of at least 11 mm.
- Skin‑contacting edge must be rounded to prevent injury; transparency required to observe skin changes.
Performance
- Negative pressure resistance: device must resist a maximum instantaneous negative pressure (specified in the standard).
- Pressure maintenance: pressure must be maintained over time (standard requires limited pressure loss over 10 minutes).
- Mechanical stability: maintain pressure after impact testing (0.5 J ±0.05 J).
- Repeated disinfection resistance: multiple‑use devices must retain performance after repeated disinfection.
Biological safety
- Biological evaluation per ISO 10993 series. Required tests vary by type:
  - Both single‑use and multiple‑use: cytotoxicity and sensitization.
  - Single‑use (blood‑contact) additionally: intracutaneous reactivity, acute systemic toxicity, hemocompatibility.
  - Ethylene oxide (EO) residual testing when EO sterilization is used.
Sterilization & disinfection
- Single‑use devices: validated sterilization per ISO 11135 / ISO 11137‑1 / ISO 17665‑1.
- Multiple‑use devices: validated disinfection procedures per ISO 17664.
Packaging & labelling
- Primary package must be sealed, free of foreign matter, protect sterility/disinfection and show evidence of opening.
- Symbols and labelling follow ISO 15223‑1; secondary packaging must protect contents during transport/storage.

Applications and users

ISO 19611 is intended for:

Manufacturers and designers of cupping devices (product specification, testing and CE/market compliance).
Quality assurance, regulatory affairs and conformity assessment teams in medical device companies.
Sterilization and reprocessing specialists defining validated processes.
Healthcare providers, clinics and procurement teams that purchase single‑use or reusable cupping cups.
Test laboratories performing performance and biocompatibility testing.

Related standards

ISO 10993 (biological evaluation)
ISO 11135, ISO 11137‑1, ISO 17665‑1 (sterilization)
ISO 17664 (reprocessing information)
ISO 15223‑1 (symbols on labels)
ISO 11607‑1 (packaging for terminally sterilized devices)

Keywords: ISO 19611, air extraction cupping device, cupping therapy, traditional Chinese medicine, negative pressure, sterilization, biocompatibility, medical device packaging.

ISO 19611:2017 PDF

Технические детали

Abstract

Overview

Key topics and technical requirements

Applications and users

Related standards

Похожие стандарты

Abstract

Overview

Key topics and technical requirements

Applications and users

Related standards

Похожие стандарты

Biological evaluation of medical devices. Tests for systemic toxicity.

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