一次性N95口罩AS/NZS 1716认证简介
Purpose or Intended Use 用途
Surgical N95 Respirators 外科N95口罩· 可以减少但不能消除空气中的生物污染物，不可以防止疾病、死亡等风险
· 用来盖住口鼻
· Require fit-testing 需要适用佩戴检查以便达到设计效果
· 用户必须遵照澳标选择、应用和维护 AS/NZS 1715 “Selection, use and maintenance of respiratory protective devices”
· Specific use instructions, warnings and limitations for use in healthcare environments.说明书需要符合标准要求，警告标语、以及使用环境等
· meet P2 requirements set forth by AS/NZS 1716 2012. 需要符合AS/NZS 1716有个P2等级认证和检测要求
Industrial N95 Respirators 工业N95口罩
· 可以减少但不能消除空气中的污染物
· 需要适用佩戴检查以便达到设计效果；用户必须遵照澳标选择、应用和维护 AS/NZS 1715 “Selection, use and maintenance of respiratory protective devices”
· 使用前，需要适用佩戴检查的要求需要依据AS/NZS 1715 Suitable fit testing procedures are provided in AS/NZS 1715 2009
· Have specific use instructions, warnings and limitations for use in industrial environments. 说明书需要符合标准要求，警告标语、以及使用环境等
· Are certified in accordance with AS/NZS 1716 2012. 要符合AS/NZS 1716有关P2等级认证和检测要求
Approval and Certification 认证
Surgical Masks 外科口罩
需要AS 4381认证，以及TGA注册，主要用来防止病人的唾液、飞沫Industrial P2 Respirators and Surgical N95 Respirators 工业P2口罩
需要AS/NZS 1716认证。P2口罩必须通过独立认可实验室的检测并且符合标准要求，比如过滤效率96%，方可申请通过独立的认证机构比如DNV GL Australia进行AS/NZS 1716的认证。针对一次性N95口罩AS/NZS 1716 & EN149部分检测项目比较
EN 149 产品类别 Particle filtering half mask EN 149: 2001 FFP2 NR KN95FFP2 是欧标EN 149根据TIL和过滤效果filtering efficiency来分类；P2是澳标AS/NZS 1716的filtering efficiency
1. TIL 呼入泄露总量 total inward leakage 标准条款
要求：10个人50个不同的动作，共50次 10 subjects x 5 ‘individual exercise’
| Cl. | Limit | |
| EN 149 |
Cl.7.9.1 Cl.8.5 |
46 out of 50, < 11% for FFP2 and 8 of 10, < 8% 50次动作的46次测试结果<11%，10个人中8个人的均值<8% |
| AS/NZS 1716 | Cl. 2.2.2 |
A mean inward leakage / individual exercise < 8% The mean inward leakage / subject < 8% |
| Cl. | Carbon dioxide content of the inhalation (Limit) 限值 | |
| EN 149 | Cl.7.12& 8.7 | no more than 1.0% 不能超过1.0% |
| AS/NZS 1716 | Cl. 3.2.2 | no more than 1.0% |
| Cl. | Test Parameter 测试方法 | |
| EN 149 | Cl.7.12& 8.7 | Breathing machine: 25 cycles /min, 2.0 L/Stroke, 5% CO2 content 呼吸机：25次/分钟；每次2L；5% CO2 |
| AS/NZS 1716 | Cl. 3.2.2, E5.3, E4(c) | Breathing machine: 20 cycles /min, 2.0 L/Stroke, 5% CO2 content |
| Cl. | Breathing resistance – exhalation | |||||
| EN 149 | Cl.7.16 | 160 L/min, < 3.0 Mbar | ||||
| AS/NZS 1716 | Cl.3.2.5 | 85 L/min, < 120 Pa | ||||
| GB 2626 |
Cl.5.5 Cl.6.6 |
85 L/min, <250 Pa, Test result: 46.3 Pa and 45.9 Pa | ||||
| Cl. | exhalation | Inhalation 呼入阻力 | ||||
| EN 149 | Table 2 |
Tested at 160 L/min |
1. Test at 30 L/min 2. Test at 95 L/min |
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| AS/NZS 1716 | 3.2.5 |
Test at 85+/- 2 L/min limit: < 120 Pa |
/ | |||
| AS/NZS 1716 | Table 4.1 | / |
1. Test at 30 L/min 2. Test at 95 L/min |
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| GB/T 2626-2006 呼吸防护用品自吸过滤式防颗粒物呼吸器 | GB/T 2626-2006 Respiratory protective equipment- Non powered air-purifying particle respirator |
| 5.5 每个样品的总吸气阻力应不大于350Pa，总呼气阻力应不大于250Pa | Cl.5.5 The total inhalation resistance of each sample shall be no more than 350Pa and the total exhalation resistance shall be no more than 250 Pa |
| 6.6.4 将被测样品佩戴在匹配的试验头模上，调整面罩的佩戴位置及头带的松紧度，确保面罩与试验头模的密合。再将通气量调节至（85+/-1）L/min，测定并记录呼气阻力。 | Cl.6.6.4 Seal the particle filtering half mask on the Sheffield dummy head, and adjust properly the wearing position of the mask with the tightness of the head strap to ensure that the mask is closely closed with the test dummy head. The continuous stream of air is then adjusted to (85+/-1) L/min, and the exhalation resistance is measured and recorded. |
Specification: P2 NR, KN95, B, AS/NZS 1716: 2012, YYYY/MM
P2: filtering efficiency classification
KN95: type of the mask
B: color code, white
AS/NZS 1716: 2012
NR: single shift use only
YYYY/MM: shelf life, i.e. 2025/04 use before 2025 April
Dimensions：162 mmx105 mm
