In a previous reading, we have developed the most important certificates of our company. As has been said several times, we very often prefer to conduct an exchange with the person we trust. What assures us and gives us confidence in this process are the certificates. And Mayamed Medical has plenty of them, which sets it apart as a medical textile company from its competitors.
Remember, in general, a certificate is a written document, official or duly signed by an authorized person who attests to a fact. The principle of a certification is to give a company's customers an assurance of quality. That is to say that the certification proves, testifies, establishes that the certified company (or the certified personnel) responds, for some of these aspects/procedures/products/services/etc. to a certain frame of reference. A certification also indicates that the company has followed an approach that complies with the regulations of international organizations such as the European Union.
In this reading we will focus on the certificates that our most requested products have, of which the products in the following list are part.
- Disposable Protective Coverall Full Protection (Type 3-B/4-B): MY 7314 is designed to protect workers against high pressure liquid jets (Type3), low pressure liquid sprays (Type 4), hazardous dust (Type 5) and light liquid splash (Type 6). These suits are intended to be worn over underwear and are designed to provide protection against incendiary electrostatic discharge if properly grounded.
- Breatheasy Coverall: The MYBC 7651 disposable breathable coverall is designed to protect the wearer's body from sensitive substances or products and processes from contamination by people.
- Disposable Protective Coverall (Type 5-B/6-B): MY 7315 is designed to protect workers against hazardous dusts (Type 5) and light liquid splashes (Type 6). These suits are intended to be worn over underwear and are designed to protect against incendiary electrostatic discharge if properly grounded.
- Surgical Gown: The MYSML 7390 surgical gown is designed to protect against the use of type liquid chemicals (Type PB (6) and protection against penetration of liquid chemicals. This type of garment protects the user against potential exposure to light or low volume spraying of dilute chemicals. These gowns also provide partial body protection against ingress of liquid chemicals in Types PB(3) and PB(4).These gowns also protect the user for a limited use against penetration of infectious agents (Type B) These gowns are intended to be worn over underwear.
- Medic Scrub: MYSC 7410 Medic Scrub, AAMI 1 meets the requirements for an AAMI Level 2 Protective Barrier for medical scrub per ANSI/AAMI PB70:2012 Liquid Barrier Performance Rating Garment drapes intended for use in health care institutions. MYSC 7410Medic Scrub is designed for use in low concentration low risk contaminated areas to prevent the risk of particle transfer. It is manufactured in accordance with EN 13485 standards.
- Chemotherapy Gown: The MYKG 7622 Chemotherapy Gown is designed to help protect against light splashes of liquid (Type PB [6]-B). Chemotherapy gowns are designed to protect caregivers and patients from contamination. These gowns have a fluid and dust barrier.
Now let's move on to the certificates of our products.
- 2016/425 PPE
- 2017/745 MDR
- ISO 9001:2015: Quality management systems
- Good Hygiene Practices (BPH)
- Good Manufacturing Practices
- ISO 45001:2018: Occupational health and safety management systems
- ISO 14001:2015: Environmental management systems
- ISO 22000:2015: FOOD SAFETY MANAGEMENT
- OIC/SMICC 1: General requirements for halal food
- SA 8000:2014: Social Accountability
- ISO13485:2016: Medical devices