Certifications
Certified to ensure quality,
safety and sustainability
ISKO+Health products are designed for a range of healthcare applications. We ensure that each of our products complies with the specific standards of its product category. Our surgical gowns and compression garments are Class I Medical Devices and comply with the EU Medical Device Regulation (MDR). All our garments are developed and manufactured in line with international quality, safety, and sustainability standards.
| Company |
Organization
ISO 9001
OHSAS 18001
Processes
ISO 14001
ISO 50001
Oeko-Tex® STeP
Industry
Sedex
| Medical Gowns |
Surgical Gowns
ISO 10993
ISO 13485
ISO 13795
ISO 15797
EU MDR 2017/45
Oeko-Tex® Standard 100
CE Mark
ICU Gowns
ISO 10993
ISO 14126
ISO 15797
Oeko-Tex® Standard 100
Light Professional Gowns
ISO 6330
Oeko-Tex® Standard 100
| Compression Wear |
Adjustable Compression Wraps
ISO 6330
ISO 10993
ISO 13485
EU MDR 2017/45
Oeko-Tex® Standard 100
RAL-GZ 387
CE Mark
Post-surgical Compression Garments
ISO 6330
ISO 10993
ISO 13485
EU MDR 2017/45
Oeko-Tex® Standard 100
RAL-GZ 387
CE Mark
Compression Clothing
ISO 6330
Oeko-Tex® Standard 100
RAL-GZ 387
Standards and Certifications
  |
ISO 6330 — Domestic Washing and Drying Standard |
| Describes how to wash garments at home or in-house to guarantee and ensure proper product performance. | |
 |
|
 |
ISO 9001 — Quality Management System Standard for Organization |
| Outlines how to run a business. | |
|
|
|
ISO 10993 — Biocompatibility Standard |
| Describes requirements for medical devices and ensures that medical devices are non-risk and non-harmful to humans. | |
|
|
|
ISO 13485 — Quality Management System Standard for Medical Devices |
| Ensures compliance with all requirements and standards for the production and sale of medical devices. | |
|
|
|
ISO 13795 — Surgical Clothing Requirements Standard |
| Describes performance and testing requirements for medical gowns used in the surgical operating environment. | |
|
|
|
ISO 14001 — Environmental Management Standard |
| Describes a core set of standards for designing and implementing optimal environmental management. | |
|
|
|
ISO 14126 — Personal Protective Equipment Standard |
| Describes performance and testing requirements for personal protective wear. | |
|
|
|
ISO 15797 — Industrial Washing and Finishing Standard |
| Describes how to industrially wash garments to guarantee and ensure proper product performance and safety. | |
|
|
|
ISO 50001 — Energy Management Standard |
| Describes requirements for establishing, implementing, maintaining, and improving an energy management system. | |
|
|
|
Oeko-Tex® Standard 100 — Textile Non-toxicity Standard |
| Ensures textile products are non-harmful and non-toxic to humans. | |
|
|
|
Oeko-Tex® STeP — Sustainable Textile and Leather Production Standard |
| Ensures that all stages of textile production and manufacturing meet specific environmental measures. | |
|
|
|
Sedex — Sustainable Supply Chain Standards |
| Outlines guidelines for empowering responsible supply chains. | |
|
|
|
RAL-GZ 387 — International Compression Standard for Garments |
| Ensures that garment compression levels are tested and certified. | |
|
|
|
CE Mark — Conformité Européenne |
| Indicates that products conform with the requirements described in the EU MDR. It is required for the sale of medical devices. | |