Physical Address
304 North Cardinal St.
Dorchester Center, MA 02124
Physical Address
304 North Cardinal St.
Dorchester Center, MA 02124
This specification covers rubber-coated cloth sheeting intended for use in the protection of mattresses on hospital beds. The base cloth shall be woven or knitted from cotton yarn, synthetic yarn, or a blend of cotton and synthetic yarn. The coating compound shall be natural rubber, synthetic rubber, or a mixture of natural and synthetic rubbers suitably formulated and colored with a white pigment to meet the requirements of this specification. Compounding materials shall be permitted in accordance with Code of Federal Regulations, Title 21, Food and Drug Administration Part 177 (Indirect Food Additives: Polymers) and Part 182 (Substances Generally Recognized as Safe). The base cloth shall be coated uniformly on both sides with equal amounts of the coating compound. The coated fabric may be dusted with a talc that does not support mildew growth. The coated cloth shall be vulcanized to meet the physical requirements of Table 1 and the performance requirements specified in Section 5.
| 🟦 Component | 📏 Specification |
|---|---|
| Base Cloth | Woven or knitted; cotton, synthetic, or blend. |
| Coating Compound | Natural rubber, synthetic rubber, or mixture; white pigment. |
| Compounding Materials | Permitted per 21 CFR Part 177 and Part 182. |
The coated cloth shall show no evidence of softening, tackiness, hardening, peeling, or blistering when exposed to a 5% phenol-water solution and a 70% isopropyl alcohol-water solution in accordance with 9.7 and 9.8. It shall show no evidence of stiffness, brittleness, tackiness, or discoloration after exposure to heat in accordance with 9.9.
| 🔬 Test | 📋 Requirement | 📐 Method |
|---|---|---|
| Resistance to Phenol | No deterioration in 5% phenol-water. | Section 9.7 |
| Resistance to Isopropyl Alcohol | No deterioration in 70% isopropyl alcohol-water. | Section 9.8 |
| Resistance to Heat Aging | No stiffness, brittleness, tackiness, or discoloration. | Section 9.9 |