Laboratory designated to testing disposable consumable hospital, dental and medical products in accordance with INMETRO Ordinances 288, 286 and 287 and ANVISA resolutions RDC 03, 04 and 05/2011.
LABELO’S Chemical Analysis laboratory was initially created to meet the needs of ANVISA/INMETRO for a laboratory qualified to conduct tests on disposable hospital, dental and medical products, with the aim of analyzing the conformity of consumables such as syringes, needles, catheters and dental accessories, among others.
With the support of FINEP and PUCRS, LABELO set up the laboratory, trained staff, underwent INMETRO inspection and accredited a series of standards with this purpose and is now qualified to perform this task, collaborating in the safety and of patients and healthcare professionals.
| Product | Tests/Ranges | Standards and/or Procedure |
|---|---|---|
| SYRINGES | Sterile single-use hypodermic syringes – Part 1: For use in syringe pumps | NBR 7886-2 |
| Sterile single–use hypodermic syringes – Part 1: Syringe for normal use | NBR ISO 7886-1 | |
| Sterile single-use syringes, with or without needles, for insulin | ABNT NBR ISO 8537 | |
| NEEDLES | Sterile single-use hypodermic needles | NBR 9259/1997 |
| Sterile single-use arteriovenous fistula needle – Requirements and testing methods | NBR 13854/1997 | |
| SURGICAL SUTURE THREAD | Surgical suture threads | NBR 13904/2003 |
| GLOVES | Surgical gloves | NBR 13391/1995 |
| Single-use gloves for medical examinations – Part 1: specification for gloves made from latex rubber or liquid rubber | NBR ISO 11193-1/2009 | |
| SYRINGES AND NEEDLES | Conical fittings with a 6% (Luer) taper for syringes, needles and other medical equipment – Part 1: General Requirements | NBR ISO 594-1/2003 |
| CATHETERS | Conical fittings with a 6% (Luer) taper for syringes, needles and other medical equipment – Part 1: Lock fittings | NBR ISO 594-2/2003 |
| Sterile single-use hypodermic needles | NBR ISO 7864/2010 | |
| Sterile single-use intravascular catheter – Part 1: General requirements | NBR ISO 10555-1/2003 | |
| Sterile single–use intravascular catheter – Part 2: Angiographic catheter | NBR ISO 10555-2/2003 | |
| Sterile single–use intravascular catheter – Part 3: Central venous catheter | NBR ISO 10555-3/2003 | |
| Sterile single–use intravascular catheter – Part 4: Balloon catheter | NBR ISO 10555-4/2003 | |
| Sterile single–use intravascular catheter – Part 5: Peripheral over the needle catheter | NBR ISO 10555-5/2003 | |
| Infusion equipment for medical use – Part 4: Infusion equipment for individual use, gravity feed |
