Purpose or IntendedUse 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
· Requirefit-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/NZS1715 “Selection, use and maintenance of respiratory protectivedevices”
· Specificuse instructions, warnings and limitations for use in healthcareenvironments.说明书需要符合标准要求，警告标语、以及使用环境等
· meet P2requirements 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/NZS1715 “Selection, use and maintenance of respiratory protectivedevices”
· 使用前，需要适用佩戴检查的要求需要依据AS/NZS 1715Suitable fit testing procedures are provided in AS/NZS 17152009
· Havespecific use instructions, warnings and limitations for use inindustrial environments. 说明书需要符合标准要求，警告标语、以及使用环境等
· Arecertified in accordance with AS/NZS 17162012. 要符合AS/NZS 1716有关P2等级认证和检测要求
Approval andCertification 认证
SurgicalMasks 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 andSurgical N95 Respirators 工业P2口罩
需要AS/NZS1716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/NZS1716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 NRKN95
FFP2是欧标EN 149根据TIL和过滤效果filteringefficiency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 10subjects x 5 ‘individual exercise’
| Cl. | Limit | |
| EN149 | Cl.7.9.1 Cl.8.5 | 46out 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/NZS1716 | Cl.2.2.2 | Amean inward leakage / individual exercise < 8% The mean inward leakage / subject < 8% |
2. CO2的含量
| Cl. | Carbon dioxide content of the inhalation (Limit) 限值 | |
| EN149 | Cl.7.12& 8.7 | nomore than 1.0% 不能超过1.0% |
| AS/NZS1716 | Cl.3.2.2 | nomore than 1.0% |
| Cl. | TestParameter 测试方法 | |
| EN149 | 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/NZS1716 | Cl.3.2.2, E5.3, E4(c) | Breathing machine: 20 cycles /min, 2.0 L/Stroke, 5% CO2content |
3. 呼出阻力
| 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 45.9Pa | ||||
| Cl. | exhalation | Inhalation 呼入阻力 | ||||
| EN149 | Table 2 | Tested at 160 L/min | 1. Test at 30 L/min 2. Test at 95 L/min | |||
| AS/NZS1716 | 3.2.5 | Testat 85+/- 2 L/min limit: < 120 Pa | / | |||
| AS/NZS1716 | Table 4.1 | / | 1. Test at 30 L/min 2. Test at 95 L/min | |||
| GB/T2626-2006 呼吸防护用品自吸过滤式防颗粒物呼吸器 | GB/T2626-2006 Respiratory protective equipment- Non poweredair-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 nomore than 350Pa and the total exhalation resistance shall be nomore 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 theSheffield dummy head, and adjust properly the wearing position ofthe mask with the tightness of the head strap to ensure that themask is closely closed with the test dummy head. Thecontinuous stream of air is then adjusted to (85+/-1) L/min, andthe exhalation resistance is measured and recorded. |
Marking标签要求(具体参见标准)
Specification:P2 NR, KN95, B, AS/NZS 1716: 2012, YYYY/MM
P2: filteringefficiency classification
KN95: type ofthe mask
B: color code,white
AS/NZS 1716:2012
NR: single shiftuse only
YYYY/MM: shelflife, i.e. 2025/04 use before 2025 April
Dimensions：162mmx105 mm
