Overview
EN ISO 21171:2006 - Medical gloves - Determination of removable surface powder (ISO 21171:2006) specifies laboratory test methods to quantify readily removable, water‑insoluble powder on the surface of medical gloves. The standard defines three procedures: Method A for powdered gloves and Methods B and C for powder‑free gloves. The test is a physicochemical method (wash, filtration, drying, weighing) and does not set safety limits or address clinical safety implications. Applicability to non‑rubber medical gloves has not been established.
Key Topics
- Principle: Surfaces of gloves are washed with distilled/deionized water; the water‑insoluble powder is collected by suction filtration, dried and weighed to determine removable powder mass.
- Sampling: Random selection from a lot. Typical sample sizes:
- Powdered gloves: 2 gloves
- Powder‑free gloves: 5 gloves (surgeon’s gloves: 6)
- Apparatus & reagents:
- Balance accurate to 0.1 mg
- Mechanical shaker (≥ 1.7 Hz)
- Drying oven (100 °C ± 5 °C)
- Glass microfiber filters (90 mm and 47 mm, 2.7 µm pore size)
- Distilled or deionized water
- Procedures:
- Method A: multiple rinses of each glove (four fresh water rinses per glove), filtration on 90 mm filter; calculation of average mg powder per glove.
- Methods B/C: similar approach for powder‑free gloves using 47 mm filter, pooled rinses, and blank runs because amounts are small.
- Calculation & Precision: The standard gives formulas to convert mass differences to mg of powder per glove and includes precision information and requirements for test reporting.
- Limitations: The standard is a test method only - it does not prescribe acceptable powder limits or safety criteria.
Applications
- Quality control for manufacturers of medical gloves to quantify removable surface powder during production and batch release.
- Incoming inspection by healthcare procurement and sterile supply units to verify supplier claims (powdered vs. powder‑free).
- Regulatory & conformity evidence when documenting product characteristics; the EN version includes relationship notes to EU medical device directives (informative).
- Laboratory and R&D use for comparative studies, process optimization, and material evaluation.
Who uses this standard
- Glove manufacturers and process engineers
- Independent testing laboratories and QC analysts
- Hospital sterile services and procurement officers
- Regulatory affairs specialists preparing technical files
Related Standards
- ISO 21171:2006 is based on ASTM D6124‑01 (Standard Test Method for Residual Powder on Medical Gloves).
- The EN version includes informative references to EU Directive 93/42/EEC (medical devices) for conformity context.
Keywords: EN ISO 21171:2006, medical gloves, removable surface powder, powdered gloves, powder‑free gloves, test method, filtration, weighing, quality control, regulatory compliance.
